Community Pharmacy

Community Pharmacy may be defined as that area of Pharmacy Practice in which medicines and other related products are sold or provided directly to the public from a retail (or other commercial) outlet designed primarily for the purpose of providing medicines. The sale or provision of the medicine may be either on the order or prescription of a doctor or "over the counter" (OTC). In addition to supplying medicines, the community pharmacist is expected to act as a primary health care professional and play a substantial role in health promotion and consumer health information. With the enforcement of the Drugs and Cosmetics Act, 1940, the sale of drugs in India has become a restricted practice and only those persons who have been granted licences by the licensing authorities of the States, can engage themselves in the wholesale, retail, compounding or dispensing of drugs. According to the Drugs and Cosmetics Act, the premises for the retail sale of drugs have been categorised as Drug Store : These retail shops do not require the services of a "Qualified Person" and can sell only such drugs where the sale does not require any technical supervision. Chemists and Druggists : These retail shops have to employ the services of a "Registered Pharmacist" and can sell all types of drugs except those drugs which have to be compounded against prescriptions. Pharmacy or Dispensing Chemist : These retail shops employ "Qualified Person" and engage in the compounding of drugs. These are required to maintain equipments and space as laid down in Schedule N to the Drugs and Cosmetics Act.

TYPES OF DRUG STORES AND DESIGN
Based on their layout design, drug stores may be categorised as

1. Traditional Drug Stores :
These types of drug stores are designed in such a manner that the entire area of drug store is exposed to customers. Such a design has pleasing and professional appearance and is convenient for both workers and customers. It provides opportunity for maximum sales but there are good chances of theft in such design.

2. Personal Service Drug Stores :
 In this type of design, the whole of the area is not exposed to the customer but the customer is required to interact with the drug store personnel at the service ii counter. During the purchasing process, the customer &glands an article and the personnel provides the article. This service and design facilitate maximum interaction between drug store employee area where the customer • expected to wait while his prescription is processed. In this type of of the personnel at the service counter. and the customers. The success of drug store depends upon the convenience and friendly service

3. Prescription Oriented Drug Stores :
These types of drug stores provide a comfortable waiting design, health related items, drugs and prescription accessories are displayed in the vicinity orthopaedic and surgical appliances are kept in a separate room. Cosmetics and gifts are arranged in a suitable area in the store.

4. Pharmaceutical Centres 
: These type of centres sell medicines, convenience articles, orthopaedic and surgical appliances. The store has sufficient floor space and is properly decorated. Orthopaedic and surgical appliances are kept in a separate room.

5. Super Drug Stores:
Such type of drug stores have a huge floor area, ranging from 5,000 to 10,000 sq. ft. with a square design. The customers have access to almost all the area in the drug store and can inspect, handle and select articles themselves. The design is on self-service pattern except for the Prescription department where self service is not possible.

SITE SELECTION
The selection of the exact site or piece of land on which the Drug Store is proposed to be established is of prime importance. The following are some of the factors which should be considered during selection of the appropriate site
1. Population Density :
 The drug store should ideally be located in a thickly populated area since this will ensure more number of customers.
2. Number of Physicians in the area :
More is the number of physicians in the area, more will be the prescription leading to more number of customers for the drug store.
3. Proximity to Physicians and other Health care Facilities:
 The drug store should preferably be located near a Hospital or a nursing home or a practising physician since this will tremendously boost up the sale of drugs as well as surgical and other accessory items.
4. Number of already existing Drug Stores :
This is an important criteria for selection of the site because more number of drug stores in an area will cause a reduction in the business of each.
5. Nearness to Market 
A drug store that is located near a market has better chances of attracting the customers.
6. Nearness to a Parking Facility
 A drug store should not be located at a place where parking becomes a problem since this will reduce the number of customers visiting the place.
7. Traffic Count :
A drug store should preferably be situated on that side of the road which falls on the route of maximum number of people returning from their work place.
8. Income Group of the People in the Area :
A drug store located in an affluent area will have better chances of doing good business because of the good purchasing capacity of the people and also because of better awareness towards their health.
9. Age group of People in the Area :
 A drug store located in an area having a large number of aged persons and infants is likely to do better business in comparison to a drug store located in an area having maximum number of young people.
10. Scope for expansion:
The site selected for a drug store should have a scope for expansion in case the need arises in future.
11. Economic factors :
The guiding principle in the selection of a site for a drug store is that it must result in the lowest unit cost in dispensing and distributing a product. The elements of total cost include cost of land and building, transportation costs of material, power and water rates, taxes and labor and administrative costs.

 LAYOUT DESIGN

Objectives of a Good layout Design :
A good layout design aims at achieving the following objectives :
(1) To ensure compliance with the legal requirements.
(ii) To ensure maximum utilization of the available space.
(iii) To reduce the running cost of the drug store.
(iv) To ensure better supervision of the store thereby reducing chances of pilferage, breakage, etc.
(v) To ensure adequate protection to the medicines against deleterious effects of light, heat and moisture.
(vi) To attract maximum number of customers into the drug store.
(vii) To increase the amount of total purchase of each person entering the drug store.
(viii) To improve the general and professional image of the store.

 Features of a Good Layout Design good stores layout design should have the following features:

(i) There should be proper ventilation facilities in the drug store to project a sense of cleanliness.
(ii) There should be proper illumination inside the drug store by using tube lights (Neon or fluorescent). Lighting by bulbs should be avoided since it presents a gloomy picture.
(iii) The walls and roof should be painted with washable paint for easy cleaning. White or light shades of colour should be used since light colours bring a feeling of cleanliness.
(iv) Sufficient number of wooden or steel racks should be provided. These should be painted hite from inside and should be fitted with glass doors.
(v) The counters should be made from wood having sunmica on top.
vi) The show windows should be tastefully decorated and should be made very attractive.
(vii) Office furniture such as table and sufficient number of chairs should be provided.
(viii) Sufficient waiting space with comfortable chairs should be provided for the customers.
(ix) All the medicines and accessories should be placed on the shelves and there should be efficient use of space and height in arranging the items. The movement of men and materials should be minimized thus saving on time, cost and surveillance.
(x) Fast moving items should he kept handy near the counter while slow moving ones may be kept at the back on upper shelves. Bulky items should be stored on bottom shelves.
(xi) Accessories and equipments such as surgical instruments, gloves, sutures, etc. should be store in separate racks specially reserved for the purpose.
(xii) Cash counter and wrapping counter should be located near the gate.
(xiii) The medicines may either be stored alphabetically or according to their therapeutic categories or according to their manufacturers.

LEGAL REQUIREMENTS FOR STARTING A DRUG STORE

The sale of drugs is quite different from the sale of other goods. In case of ordinary goods, the consumer can select the goods according to his choice but in case of drugs, the choice is in the hands of a physician. Moreover, the sale of drugs is a technical job and must be performed by a qualified person. Before opening a drug store (whether retail or whole sale), there are certain legal requirements which must be fulfilled.

1. Minimum Qualifications
 A person who wishes to start a retail drug store should either be a registered pharmacist himself or should engage the services of a registered pharmacist. In order to become a Registered Pharmacist, a person should fulfil the requirements laid down in the Pharmacy Act which include the following:

(i) The person should have attained at least 18 years of age.
(ii) He should be a resident of the state or should be carrying out his business or profession of pharmacy in the state.
(iii) Should possess a degree of diploma in Pharmacy or any other approved qualification.

A person who wishes to start a wholesale drug store may not be a registered pharmacist but must have passed at least matriculation examination and must possess at least four years experience in handling of drugs.

 2. Minimum Space:
A minimum area of 10 square meters is required for running a retail or wholesale drug store. The tow ch area should be equipped with proper storage facility for preserving the properties of drugs to the licence applies. For the storage of thermolabile substances such as vaccines, sera, enzymatic  preparations, antibiotics, vitamins, etc, a refrigerator is required in order to store these drugs at a temperature be V between 2°C and C. There should be sufficient number of storage racks for storing the drugs and Pharmaceuticalssin case of a Pnarmacy, the requirements as specified in Schedule N to the Drugs and Cosmetics Act should be fulfilled.

3. Application for Grant of Licence categories:
For the purpose of granting sale licences, the drugs have been divided into the following
(I) Drugs specified in. Schedule C and C1 to the Drugs & Cosmetics Act.
(ii) Drugs specified in Schedule X to the Drugs & Cosmetics Act.
(iii) Drugs other than those specified in Schedule C, C1 and X. The retail and wholesale licences are granted with respect to all the above three categories. Any person desirous of getting a licence to sell, stock, exhibit or offer for sale or distribute the drugs should apply to the licensing authorities appointed by the respective State Governments along with the following documents:

(i) Application Form No. 19 (for drugs other than those specified in Schedule X) and/or Form No. 19C (for drugs specified in Schedule X), duly filled in and in duplicate.
 (ii) A fee receipt of Rs 40/- for each category of licence required, to be attached with the application form.
(iii) The following documents as proof of age and qualification of the person

(a) An attested copy of proof of passing the Diploma or Degree course in Pharmacy from an institution recognised by the Pharmacy Council of India.
(b) An attested copy of proof of undergoing 750 hours of practical training in any Hospital. Dispensary or Chemist shop as recommended by Pharmacy Council of India.
(c) An attested copy of the Registration certificate issued by the State Pharmacy Council as proof of being registered.
(d) An attested copy of matriculation certificate as a proof of date of birth.
(e) In case the proprietor of the drug store is not qualified, then an affidavit from a qualified person is to be attached with the application form. In case the licence is required for wholesale of drugs, then a proof of passing the matriculation examination or its equivalent with four years experience in dealing with drugs is to be attached with the application. 

(iv) A layout plan of the drug store duly signed by the proprietor /partners of the firm.
(v) In case two or more persons are partners for starting the drug store. then a Copy of the partnership deed is to be attached with the application.
(vi) If the applicant is the owner of the premises where the drug store is to be started then the legal documents as a proof of ownership or if the premise is on rent, then a copy of rent receipt  or rent deed is to be attached with the application form.

(vii) An affidavit of non-conviction under Drugs and Cosmetics Act, by the proprietor or partners on Rs 3/- non-judicial stamp paper. duly attested by a first class magistrate is to be attached.

After scrutinizing the application form and all documents and if all the requirements are fulfilled. then the drug control authorities will personally visit the premises for which the license is required.. lf the authorities are satisfied, then the licence for the sale of drugs may be issued on the following forms as the case may be : 

(i ) For Retail Sale : 

(a) Form 20 for drugs other than those specified in Schedule C, Cl and X. 

(b) Form 21 for drugs specified in Schedule C and C1 and excluding X. 

(c) Form 20F for drugs specified in Schedule X.

ii) For Whole Sale : 

(a) Form 20B for drugs other than those specified in Schedule C, Ciand X.

(b) Form 21B lor drugs specified in Schedule C and Ci and excluding X. 

(c) Form 20G for drugs specified in Schedule X. 

4. Conditions of Licence 

The licence for the sale of drugs are granted based on certain conditions including the following : 

(i) The licence shall be displayed in a prominent place in a part of the premises open to the public. 

(ii) The licensee shall comply with the provisions of the Drugs and Cosmetics Act, 190 and Rules there under for the time being in force. 

(iii) No drug, shall be sold unless such drug is purchased under cash or credit memo from a duly licensed dealer or a duly licenced manufacturer.

(iv) No Physician's Sample (not for sale) or expired drugs will be stocked on the sale premises. 

However. expired drugs may be kept in separate packages or carton, the top of which shall display prominently the words 'Not for Sale'. 

(v) No drug belonging to ESI, CGHS, Armed Forces Medical store or a Government Hospital shall be present in the licensed premises. 

(vi) In case of Pharmacy, the compounding of the prescription would be done under the personal supervision of a Qualified Person. 

(vii) All registers and records required to be maintained under the Act would be preserved for a period of at least 2 years from the date of the last entry therein. 

viii) The licence will be renewed as and when required.

 (ix) Any change in ownership or "Qualified person" shall be notified to the licensing authority within  three months.

 6. Duration of Licence:

A licence for the sale of drugs remains valid upto 31st December of the year following the year  ill which the licence is  granted or renewed.

7, Renewal of Licence : 

 Application for the renewal of the licence may be made before the expiry or within six months of the date of its expiry, along with late fees. The licence shall be deemed to have expired if the application for renewal of licence is not made within six months after its expiry. In the event of do change in constitution of a licensed firm, the licensee shall inform the licensing of change unless in the authority. Licences of such firms are deemed to be valid for a period of three months from the date meantime a fresh licence has been obtained. 

STORAGE OF DRUGS 

Drugs should be stored in a manner that preserves their potency for the desired period of time. with. The manufacturers instruction on the label regarding the storage of the product should be complied 

Storage of Schedule X Drugs and Drugs with Expiry Dates:

Substances specified in Schedule X should be stored under lock and key in cupboard or drawer reserved solely for the storage of these substances; or in a part of the premises separate from the remainder of the premises and for which only responsible persons have_ access. Other drugs with an expiry date should be stored in a separate cupboard. 

Storage of Veterinary Drugs:

Veterinary drugs should be stored in a cupboard or drawer reserved for the storage of veterinary drugs in a portion of the premises separated from the remainder of the premises to which customers are not permitted to have access. 

DISPENSING OF PROPRIETARY PRODUCTS 

Prescriptions, now-a-days are usually written for preformulated proprietary medicines and the pharmacist has only to dispense them in a proper manner. However, all dispensing of Proprietary products is required to be done either by the Registered Pharmacist himself or under his direct supervision. The following procedure may be adopted during dispensing of such products 

1. Receiving the Prescription: 

The prescription should be received by the pharmacist himself, wherever possible or a person trained properly to do so in a professional manner. The patient should be informed about the approximate time required for filling the prescription. 

2. Reading and Checking the Prescription : 

On receiving the prescription, the pharmacist should first read the prescription completely and carefully. He should verify that the name and address of the patient are correct, the prescription is legally valid and is written correctly. He should not express any doubt regarding the contents of the prescription ether to to the patient or to his messenger, in manner which questions the wisdom of the prescribing physician.  

 The pharmacist should not add, omit or substitute any content of the prescription without the consent of the physician.

 3. Dispensing, Packing and Labelling

 The medicine should he selected from the stock and if in unit dosage form such as tablets or capsules, the correct number should be counted and filled into previously selected containers, The labels of all containers of stock drugs should he checked when selected from and replaced in stock, as well as at the time of actual dispensing, making three checks in total. Any subsidiary label required should be properly affixed to the container. The container must be thoroughly polished to remove any finger prints.

 4. Finishing :

 The final product, the prescription and the labels should be rechecked before handing over to the patient. All records must be completed including those required by legislation. The patient or his representative should be explained about the proper mode of administration and storage of the medicine. preferably in their local language. Dispensing of Schedule H and X Drugs Substances specified in Schedule H and X to the Drugs and Cosmetics Act should not be sold by retail except on the prescription of a Registered Medical Practitioner and in case of substances specified in Schedule X, prescriptions should be in duplicate, one copy of which shall be retained b‘ the licensee for a period of 2 years. A prescription for Schedule H and X drugs should be : 

(i) In writing and signed by the prescriber and dated by him.

(ii) Specify the name and address of the patient or the owner of the animal if the drug is meant for veterinary use.

(iii) Indicate the total amount of medicine to be supplied and the dose to be given. 

The prescriptions for Schedule H and X drugs must not be dispensed more than once unless the prescriber has stated thereon that it may be dispensed more than once; however it may be dispensed at stated number of times or at stated intervals of time in accordance with the directions of the prescriber. At the time of dispensing there must be noted on the prescription above the signature of prescribe. the name and address of the seller and the date of dispensing. 

MAINTENANCE OF RECORDS OF  RETAIL AND WHOLE SALE DRUG STORES

Records of Purchase of Drugs : 

The records Pertaining to the purchase of all drugs whether intended to he sold by retail or by wholesale should be maintained under the following headings

 (i) Date of purchase. 

(ii) Name and address of the licensee front whom  

(iii) Name and quantity of the dru purchased and his licence numhet, g and its batch number. 

(iv) Name of the manufacturer of the drug. Purchase bills including cash or credit memos should be kept as records.

 Records of Sale of Drugs : 

Sale of Drugs other than those specified in Schedule X:
 Sale of any drug other than those specified in Schedule X is required to be recorded at the time of supply in a prescribed register maintained for the purpose or in a cash or credit memo book. 

The following particulars are required to be entered 

(i) Serial number of the entry. 

(ii) Date of supply. 

(iii) Name and address of the prescriber. 

(iv) Name and address of the patient or the name and address of the owner of the animal f the drug is supplied for the veterinary use. 

(vi) Names along with the quantities of drugs supplied. 

(vii) In case of Schedule H and C drugs, the name of the manufacturer, its batch number and the expiry date, if any. 

(viii) Signature of the registered pharmacist under whose supervision the medicine was made or supplied.

Sale of Drugs specified in Schedule X:
Supply of Schedule X drugs should be recorded at the time of supply in a bound and serial numbered register maintained for this purpose and separate pages should be allotted for each drugs. 

The following particulars should he entered in the said register 

(1) Date of Purchase. supplier

(ii) Quantity received, if any, the name and address of supplier and the licence number of the .

(iii) Name and quantity of the drug supplied. 

(iv) Manufacturer's name, batch or lot number. 

(v) Name and address of the patient/purchaser. 

(vi) Reference number of the prescription against which supplies were made. 

(vii) Bill number and date of receipt of purchase and supply made by him. 

(viii) Signature of the person under whose supervision the drugs have been supplied. 

ROLE OF PHARMACIST IN HEALTH CARE AND PATIENT EDUCATION

Patient Education, as it relates to pharmacy practice, may he defined as an intervention designed to improve the patient's knowledge about drugs, his compliance with the dosage regimen and outcome of the therapy. In addition to improving knowledge, patient education must motivate patients to recognize the importance of the prescribed therapy. Patient education may be verbal, written or audio-visual. Verbal education may be provided to individual patients or to small groups of patients. Written information can include special labels for different dosage forms, patient package inserts, special information leaflets designed by individual pharmacists or organizations and booklets. Audio-visual programmes may include slides or video programs. A combination of verbal and written counselling or a combination of verbal counselling with audiovisual aids is generally better than the use of traditional written matter only. 

PATIENT COUNSELLING 

Patient Counselling may be defined as a one-on-one, interactive session between a pharmacist and the patient, designed to modify the patient's knowledge and behaviour. Patient Counselling typically provides extensive individualised information in order to overcome barriers to appropriate therapy. Patient Counselling is most effective when the patient actively participates in the session. After receipt of a new prescription and following a review.of the patient's record, a pharmacist should initiate the discussion with the patient or care-giver of a patient. 

When conducting the session, the pharmacist must always be aware of the patient's verbal and nonverbal message and barriers to effective communication. The discussion may include the following elements 

(i) The name and description of the drug. 

ii) The dosage form, dose, route of administration, dosing schedule and duration of drug therapy. 

(iii) Intended use of the drug and expected action. 

(iv) Special directions and precautions for preparation, administration, and use by the patient.

 v) Common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur. 

(vi) Techniques for self-monitoring drug therapy. 

(vii) Proper storage of drugs. 

(viii ) Prescription refill information. 

( ix ) Action to be taken in the event of a missed dose. Pharmacist comments relevant to the individual's drug therapy, including any other information specific to the patient or drug. 

Alternative forms of video programs, etc. patient information such as written information, pictogram labels, may also he used, when deemed necessary in the the pharmacist to supplement the patient counselling, sessions. 

ROLE OF THE PHARMACIST IN COMMUNITY HEALTH CARE 

The role of Pharmacist is to act in an important and responsible manner for the propagation of national health programmes. Many of our health programmes need intervention 01 all heaithcare professionals from all areas for its successful implementation. The pharmacist has a number of roles to play as outlined below :

 1. As a Quality Drug Supplier : 

(i) The pharmacist must ensure that the products he/she purchases are from reputable sources and of good quality. 

(ii) The pharmacist must ensure the proper storage of these products. 

(iii) The pharmacist should dispense the medication •in a professional manner. 

2. As a Communicator:

(i) The pharmacist should initiate dialogue with the patient (and the patient's physician, when necessary) to obtain a sufficiently detailed medication history. 

(ii) In order to address the condition of the patient appropriately the pharmacist must ask the patient key questions and pass on relevant information to him or her. 

(iii) The pharmacist must provide objective information about medicines to the patient. 

(iv) The pharmacist must be able to use and interpret additional sources of information to satisfy the needs of the patient. 

(v) The pharmacist should be able to help the patient undertake appropriate and responsible self-medication or.. when necessary, refer the patient for medical advice. 

(vi) The pharmacist must ensure confidentiality concerning details of the patient's condition..

3. As a Trainer and Supervisor 

(i) To ensure up-to-date quality service, the pharmacist must participate in continuing professional development activities such as continuing education. 

(ii) The pharmacist must ensure that the services rendered by his subordinate staff correspond to established standards of practice. 

(iii) The pharmacist must also promote the training and supervise the work of non-pharmacist staff.

Minimum Wages Acts 1948

Objectives of the Act

• To provide minimum wages to the workers working in organized sector 
• To stop exploitation of the workers
• To empower the government to take steps for fixing minimum wages and to revising it in a timely manner 
• To apply this law on most of the sections in organized sector (scheduled employment)

Historical Backdrop

The initiative by Shri K.G.R.Choudhary in 1920: set up boards for determination of wages

The International Labour Conference adopted convention 26 and 30 in 1928 relating to wage fixing machinery in trades or parts of trades

 A Minimum Wages Bill was introduced in the Central. Legislative Assembly on 11.4.46 and came into force with effect from 15.3.48

The Committee on Fair Wage was set up in 1948 to provide guidelines for wage structure

Broad Features of the Act

[Sec 3]: The Act lays down the principles  for fixation of

• A minimum time rate of wages

• A minimum piece rate

• A guaranteed time rate

• An overtime rate for different occupations, localities or classes of work and for adults, adolescents, children and apprentices

[Sec 4]: The minimum wages may consist of

• A basic rate of wages and a cost of living of allowances

• A basic rate of wages with or without the cost of living allowance and the cash value of the concessions in respect of essential commodities supplied at concessional rates

Short Title and Extent [Sec. 1]

• This Act, the Minimum Wages Act, 1948 extends to the whole of India
• This Act may be called the Minimum Wages Act, 1948

Who all are eligible?

• Permanent employees
• Contract employees
• Casual workers
• People on probation get fixed pay instead of minimum wages.
• Trainees get stipend and not minimum wages

What  is appropriate  government? [Sec 2(b)] 

• In relation to scheduled employment carried on Central Government or railways or est. under Central Act, the Central Government
• In all other cases - the State Government

Wages [Sec. 2(h)]

• Minimum wages: all remuneration capable of being paid in money terms for work done if terms of contract were fulfilled
• consist of Basic + Dearness Allowance + House Rent Allowance
• Every 5 years, basic rates of every industry are decided by Minimum Wages Committee
• Dearness Allowance changes every six months and is decided by Government
• Other Definitions

Section No.
2 (bb)	Child
2 (a)	Adolescent
2 (aa)	Adult
2 (c)	Competent authority
2 (d)	Cost of Living Index Number
2 (e)	Employer
2 (g)	Scheduled Employment
2 (i)	Employee

 Fixing minimum rate of wages [Sec. 3]

The Appropriate Government:

·         Shall fix minimum rates of wages for an employment specified in Part I or Part II of Schedule 86 added by notification in official gazette

·         May fix rates for a part of the state or for any specific class or classes instead of fixing minimum rate of wages for whole state

·         Shall review and revise at intervals not exceeding 5 years the minimum rates of wages

Different Minimum Wages May Be Fixed By The Government For:

·         Different employments (specified in the schedule)

·         Different classes (e.g. skilled, unskilled, semis skilled, etc.) of work in the same employments

·         Adults, adolescents, children and apprentices

·         Different localities

Segregation

Minimum rates of wages may be fixed by any one or more of the following wage periods, namely: 

• By the hour 
• By the day 
• By the month 
• By such other larger wage period as may be prescribed; and where such rates are fixed by the day or by the month, the manner of calculating wages for a month or for a day, as the case may be, may be indicated

 Different Minimum Wages May Be Fixed By The Government May consist of [Sec. 4]

1.       Basic + Special Allowance (Which varies with the cost of living index)

2.       Basic + Cash value of concessional supply of materials like food, clothes, etc

3.        An all inclusive rate which includes Basic + Cost of living Allowance + Cash value of 1 concessional supply of materials

Fixing Minimum Rates of Wages [Sec. 5]

• Publish its proposals in the official gazette asking comments from the affected parties
• Constitute committees/sub committees for the purpose. 
• The committees/ sub-committees and advisory boards constituted by the Government consist of equal number of members of : 

• Employers
• Employees, and
• Independent persons

Advisory Board [Sec.7]

• Appointed by appropriate government

• To co-ordinate the work of committees and sub committees appointed under Section 5

Central Advisory Board [Sec. 8]

To advise the Central and State Governments in fixation and revision of minimum rates of wages To co-ordinate the work of the Advisory Boards

Composition of Committees, etc. [Sec. 9]

Each of the committee, sub-committee and the Advisory Board shall consist of:

a. persons to be nominated by the appropriate Government

b. representing the employers and employees in the scheduled employments who shall be equal in number and

c. independent persons not exceeding one-third of its total number of members: one of such independent persons shall be appointed the Chairman by the appropriate Government.

 Correction of errors [Sec. 10]

• By appropriate Government at any time
• By notification in the Official Gazette
• Correct clerical or arithmetical mistakes or errors arising from and accidental slip or omission.
• Every such notification shall be placed before the Advisory Board for information.

 Wages in Kind [Sec. 11]

• Minimum wages shall be paid in cash. 
• The appropriate govt. may authorize, where there has been a custom of payment in this manner, payment of minimum wages either wholly or partly in kind 
• The appropriate govt. may authorize supply of essential commodities at concessional rates

 Minimum paymrent  rate of wages [Sec. 12]

• The Minimum Wages has to be paid without any deductions other than Statutory Deductions.

• Payment of wages less than minimum wages on the ground of less performance or output is illegal

Normal working works [Sec. 13]

For an Adult Worker working in Factories:

·         Number of Working Hours should not exceed 48 Hours in a week with a weekly Holiday

·         The Daily Hours should not exceed more than 9 Hours with 1 Hour Rest Interval

·         Provision of Compensatory Holiday/ Overtime Wages if working on holiday

 Overtime wages [Sec. 14]

·         If the person has worked for more than 48 hours in a week then, the excess hours worked will be treated as Overtime

·         Overtime wage rate will be twice of the normal wage rate

Wages for a person who has worked less than normal working hours [Sec. 15]

·         Employer could not provide the activities of the job then, the employee is entitled to receive full salary

·         Employee has not worked due to his unwillingness then, the employee is not entitled to receive full salary

Records to be maintained [sec. 18]

The Registers should contain the following particulars-

(i)                  particulars of employed persons

(ii)                 the work performed by them

(iii)               the wages paid to them

(iv)              the receipts given by them

Claims [Sec. 20]

·         A Labour Commissioner or any other appointed authority is authorized to hear claims regarding non-payment of minimum wages

·         Any aggrieved person may apply to the authority for settling his claims within 6 months

Penalties [Sec. 22]
Offence	Punishment
Payment of less than Minimum Wages to employee	Imprisonment which may extend up to 6 Months or Fine which may extend up to Rs 500/- or Both Contracting out [Sec. 25]

Any contract or agreement, whether made before or after the commencement of this Act, whereby an employee either relinquishes or reduces his right to a minimum rate of wages or any privilege or concession accruing to him under this Act shall be null and void so far as it purports to reduce the minimum rate of wages fixed under this Act.

Power of State Government to add schedule [Sec. 27]

• The State Government has to notify in the Official Gazette not less than three months of its intention to do so
• Power of Central Government to give directions [Sec. 28]
• The Central Government may give directions to a State Government as to the carrying into execution of this Act in the State.

Power of the central Government to make rules [Sec. 29]

• Procedure to be followed in conduct business
•  Method of voting
•  Manner of filling of casual vacancies in membership
• Quorum necessary for the transaction of business of the Central Advisory Board.

List of some important forms

Form No.	Rule	Description
III	21 (4a)	Annual Return
V	26 (5)	Muster Roll
X	26 (1)	Register of Wages
XI	26 (2)	Wage slip

Quality control of suspensions

A number of procedures have been suggested in the past for evaluating the physical stability of suspensions. Some of these are empirical in the sense that they have no mathematical base. Some methods currently being used are so drastic that they destroy the structure of the suspension. The methods used may be categorized as:

(a) Sedimentation methods:

 Since formation of the sediment and its redispersibility are two features related to the overall acceptability of suspensions, many evaluation procedures centre around sedimentation properties.

The simplest procedure for evaluation is to keep a measured volume of the suspension in a graduated cylinder in an undisturbed state for a certain period of time and note the volume of the sediment, which is expressed as ultimate height (hu). This, in relation to the initial volume of the suspension, (Ho) is expressed as sedimentation ratio. It should, however, be noted that sedimentation ratio (hu/Ho) is dependent on time and it is likely to vary at different periods of time. The sedimentation ratios at different periods of time can be plotted against time abscissa to give a curve that indicates the sedimentation pattern on storage. If the curve is horizontal to time axis it indicates a better suspension. However, if it steeps down it indicates a poor formulation. Sometimes it may be useful to dilute original suspension to known extents before determination of sedimentation ratios.

(b) Rheological methods:

 Evaluation of rheological behaviour of the suspension can help in predicting the settling pattern and can also provide clues to vehicle particle structure. In carrying out rheological study of a suspension generally low shear rates are employed and samples are evaluated undisturbed. By use of a Brookfield viscometer with T-spindle the rheological reatures at different depths in a sample can be studies. Data collected on samples stored for various periods of time can give useful information about the stability of the suspension.

(c) Electrokinetic methods:

 As has been discussed in the chapter on emulsions, the surface electric charge or zeta potential is instrumental in deciding the stability of disperse phase systems. Certain zeta potentials produce more stable suspension because of controlled flocculation. Hence, determination of zeta potential of a suspension can give valuable clues to its stability. The migration velocities of particles can be measured by electrophoretic methods and zeta potential calculated from it.

(d) Micromeritic methods: 

In the ultimate, the stability of a suspension is inter-related to the size of particles constituting its disperse phase. A growth in the particle size is a pointer towards its instability since such an occurrence can ultimately result in the formation of lumps or cake destroying the physical structure of a suspension and rendering it useless. Hence, an appreciation of change in particle size with passage of time can provide an insight into the stability aspect of a suspension. Changes in absolute particle size, particle size distribution, crystal habit etc. can be worked out by microscopy, coulter counter etc.

Quality control of emulsions

Evaluation is a necessary step in any formula development since it enables the development scientist to know whether his product possess the projected qualities or not. In biphasic products like emulsions the stability of physical structure is of paramount significance. The following evaluatory tests are usually done on the emulsions.

(a) Phase separation :

The rate and degree of phase separation in an emulsion can be easily determined by keeping a certain amount in a graduated cylinder and measuring the volume of separated phase after definite time intervals. The phase separation may result from creaming or coalescence of globules and these possibilities should be kept in mind.

Coalescence is a definite sign of instability and it generally becomes apparent within a month in instable formulations. The phase separation test can be accelerated by centrifugation at low/moderate speeds. One can at best expect a mixture of creamed and coalesced particles and in such a situation it may be difficult to make correct interpretations. High speed centrifugation (2,00,000 g) can be used to test the strength of interfacial films. At such speeds poor emulsions would crack up completely while only those with tough interfacial films may survive.

(b) Globule size :

Growth in the globule size after the preparation of an emulsion is an indication of its physical instability. Hence, size of globules and their size distribution is generally ascertained in an emulsion over a certain time span. In the beginning there generally occurs some change in the size but it may be due to inadequate surface coverage of globules by surfactants. Thereafter in a good formulation the globule size gets stabilized. If the globule size continues to grow it is indicative of a poor product which may get completely disorganized with time. The globule size is measured by microscopic methods or by electronic devices such as coulter counters. In either of these two techniques the original product has to be suitably diluted before estimations. This may introduce errors because of incomplete deflocculation or new patterns of flocculation in diluted emulsions. Hence, while making a judgement about the stability of the emulsion this aspect should be kept in mind.

(c) Flow properties: 

The rheological characteristics of an emulsion system depend upon globule size, emulsifier and its concentration, phase volume ratio etc., and hence determination of its flow characteristics could serve as an index of its stability. Therefore study of flow behavior of an emulsion is an integral part of its evaluation. Since most emulsions have non-Newtonion flow results may tend to differ if only one point viscosity measurements are made. Many emulsions exist in a flocculated state and disturbance caused due to measurements results in structure which may be contributing to their consistency. Use of a heliapath attachment with Brookfield viscometer helps in detection of creaming tendency and hence it is advisable to study rheological properties over extended periods of time can help in prediction of their long-term behaviors. Many emulsions show change in consistency with time which follows linear relationship when plotted on a log-log scale over a number of ten fold time intervals.

(d) Effect of thermal stresses: 

It is usual to evaluate the stability of an emulsion by subjecting it to high and low temperature in alternating cycles. The samples are first exposed to 60°C for a few hours and then to 0 to 4°C. Such exposures are repeated a number of times and emulsion stability assessed after each cycle. Such thermal stresses are in fact hard treatments and emulsions that survive them can be deemed to be really robust. It is to be noted that these thermal stresses cannot be directly correlated to actual shelf life situations. However, the extremes of temperatures may influence partitioning of the emulgent between the two phases or cause melting or crystallization of some fatty components and this gives an indirect clue to emulsion stability. The effect of thermal stresses on different emulsions do not follow any set pattern and vary from formulation to formulation. It has also not been possible to compute emulsion stability at room temperatures from its behavior at high temperatures. This evaluation has its significance in the fact that no formulator can possibly wait for years to evaluate shelf life of his product and hence he subjects the same to magnified artificial stresses in order to get some feel about structure stability. He may in this process accumulate valuable data which ultimately enables him to differentiate between “good” and “bad” products.

Quality control of capsules

The evaluation of capsules, in general, follows the line for compressed tablets and tests like the weight variations test, content uniformity test, disintegration and dissolution time.

Weight variation : 

This test is done by taking 20 capsules individually, determining average weight per capsule and finding out weight variation of each capsule against the average value(± 10% variations are permitted). However, if the variations are beyond this limit net weight of contents of each capsule should be determined, and compared with average net weight. This will remove any doubt about the possible variation in the weights of individual shells. As per standards specified in some Pharmacopoeias net weight of not more than two capsules should differ by more than ± 10% from the average net weight and no capsule should differ by more than ± 25%. If the average net weights of 2 to 6 capsules deviate by ± 10 to 25%, net weights of 40 more capsules should be determined. In a total of 60 capsules not more than six should deviate from average by more than ± 10% and none by more than ±25%.

Disintegration and dissolution time :

 Capsules are not normally tested for disintegration as their shells are known to dissolve rapidly in the gastric fluids. However, capsules which are designed to be enteric, by treatment of their shells with formaldehyde, should be tested thus to ensure than they do not disintegrate in simulated gastric juice under simulated conditions. Dissolution time tests are run on the lines of compressed tablets. Any of the standard apparatus available for dissolution tests can be employed. The determination of dissolution time is important since absorption of drugs depends upon their dissolution times.

Drug content uniformity :

 In solid dosage forms uniform distribution of medicaments remains a problem. The problem becomes more acute with potent medicaments administered in low doses. Hence, a number of capsules should be selected and assayed for drug content individually. Pharmacopoeias specify 30 capsules out of which 10 should be assayed individually in the first instance. Out of these at least 9 should be within ±15% of average and none should be beyond ±25. If 1 to 3 capsules out of the 10 assayed originally fall outside ±15% the remaining 20 should be assayed. Out of the total 30 capsules at least 27 should be within ±15% and no capsule should be beyond ±25%.

Quality control of tablets

Tablets may be evaluated for their physical characteristics, drug contents, dissolution sites, rate of release of drug etc. Certain physical properties of drugs like uniformity of weight, hardness, friability, thickness, disintegration and dissolution times are important characteristics having a bearing on their handling and use.

(1) Weight Uniformity:

It is desirable that every individual tablet in a batch is uniform in weight, and the weight variation, if any, is within the permissible limits (generally ± 5% for tablets weighing more than 325 mg). Non-uniformity in weights can lead to variation in dosaging. Hence, all finished bathes of tablets should be sampled and tested for weight uniformity. Generally 20 tablets are weighed collectively and individually. From the collective weight average weight per tablet is calculated. The weights of individual tablets are then compared with the average weight to ascertain whether the variations in weights are within permissible limits or not. Some of the basic causes of weight variation of tablets are faulty incorporation of glidants and resultant poor flow of granules, wide variations in granule sizes, differences in lower punch length, improper lubricants etc.

(2) Hardness :

hardness of a tablet is indicative of its tensile strength and is measured in terms of load/pressure required to crush it when placed on its edge. A number of handy hardness testers such as, Mosanto type or Pfizer type are currently in use. A tablet hardness of about 5 kg is considered to be minimum for uncoated tablets for mechanical stability. The hardness is a function of physical properties of granules like their hardness and deformation under load, binders and above all the compressional force. The hardness has influence on disintegration and dissolution times and is as such a factor that may affect bioavailabilities.

(3) Thickness :

The thickness of a tablet depends mainly upon die filling, physical properties of materials to be compressed and compressional forces. There is bound to be a small variation in the thicknesses of individual tablets in a batch but it should be of such an order that it does not immediately become apparent to unaided eye. The thickness can be easily measured by micrometers or in holding trays with sliding caliper scale. Thickness should not vary beyond ± 5% of the standard value.

(4) Friability :

Friability generally refers to loss in weight of tablets in the containers due to removal of fine particles from their surfaces. However, in wider sense chipping and fragmentations can also be included in friability. Friability generally reflects poor cohesion o tablet ingredients. Standard devices have been fabricated to measure friabilities. Generally such instruments, marketed as `Friability Test Apparatus’ or `Friabilators’, consist of a circular plastic chamber, divided into 2-3 compartments. The chamber rotates at a speed of 25 r.p.m. and drops the tablets by a distance of 15 cms. Preweighed tablets are placed in the apparatus which is given 100 revolutions after which the tablets are weighed once again. The difference in the two weights represents friability. The weight loss should not be more than one percent.