Different Schedules of the D and C Act 1940 and its rules 1945 :
1) First Schedule: It consists of the list of approved Ayurvedic, Siddha, Unani and Homeopathic Books of reference for their Manufacture and sale.
2) Second Schedule: It consists of the standards prescribed for the Drugs Imported, Manufactured and sold or meant to be stocked, distributed and sold in the market.
3) Schedule ‘A’: it consists of the list of different types of application firms to be used for obtaining licenses for Importing, manufacturing, distributing and selling the Drugs and Cosmetics.
4) Schedule ‘C’: it consists of the list of all biological and special prepns like ophthalmic prepns, sterile disposable devices and all types of parenteral preparations like Sera, Vaccines, Insulin, Adrenaline, Steroids, Antibiotics etc., including Human blood.
5) Schedule ‘C’ 1: It consists of the list of all the types of biological and special prepns like liver extract, Hormonal, prepns, vitamins and Antibiotics meant for oral use.
6) Schedule ‘F’: It consists of the requirements to be fulfilled and G.M.P. to be followed by a Blood Bank.
7) Schedule ‘G’ : it consists of the list of Drugs which should be used only under medical supervision, Ex: All types of Insulin, Aminopterin, Pheniramine,Busutfan, Chlorpropamide, Metformin, Glibenclamide, tolbutamide etc.,
8) Schedule ‘H’ : It consists of the list of Drugs which should be sold only on the prescription of an R.M.P. Ex : All types of Antibiotics, Insulin, Ranitidine, Diclofenac, Allopurinol, Arsenic compounds Steroids, Diazepam, Chloral hydrate etc.,
9) Schedule ‘J’: It consists of the list of diseases for which a Drug should not claim directly to cure such diseases. Ex: Appendicitis, Blindness, Cancer, Diabetes, Disorders of Brain, Nervous system, Uterus, Epilepsy, any type of female disorders, Gangrene, Heart diseases, cholera, Plague, Typhoid, Aids, Sexual disorders Tuberculosis Etc.
10) Schedule ‘M’: Requirements of a factory premises to be fulfilled including plants and equipments and G.M.P to be followed in it for the Manufacture of Drugs and Cosmetics meant for sale.
11) Schedule ‘N’: It consists of requirements to be fulfilled including, equipments, Apparatus, Books and journals to be provided for the efficient running of a Dispensing Pharmacy.
12) Schedule P : it consists of the list of Drugs with their life periods Ex: Adrenaline injection : 12 months, penicillin: 24 months, chloramphenicol tabs and capsules: 60 months , Cobra venom:3 months , Insulin, inj : 24 months, liquid plasma: 24 months, Diphtheria
Vaccine: 24 months, Human blood: 14 days( 2 months maximum), B.C.G. Vaccine: 14 days (liq) 1yr (Freeze-dried) etc.
13) Schedule Q:List of colours permitted to be used in Cosmetics
Ex: Tetrazine (19140), sunset yellow (15985), Amaranth (16185), Fast Green (42053)
14) Schedule X : List of Drugs likely to be abused and requires two copies of a prescription from an R.M.P. for their sale ex: Amobarbital Cyclobarbital, Pentobarbital, Phenobarbital, amphetamine, Dexamphetamine, Methamphetamine etc.
15) Schedule V: Standards prescribed for patent and proprietary medicines including vitamins.
16) Schedule Y: Consist of guidelines prescribed for carrying out clinical trials on the newly invented Drugs and conditions to be fulfilled for the manufacturing of new Drugs meant for sale.
Schedule ‘M’ of DRUGS AND COSMETICS ACT :
It consists of the requirement of a Manufacturing ( factory ) premises of Drugs and Cosmetics including “Good manufacturing Practices” (GMP) to be followed
The term GMP (Good Manufacturing Practices) was included under schedule ‘M’ after GATT (General Agreement on Trade and Tariff) signed by 23 countries including India on October 30, 1947, which was amended in 1996 as a part and parcel of WTO agreement 1996 in which various guidelines were prescribed for “Good Manufacturing practices” to ensure the best quality of Drugs and Cosmetics Manufactured in a licensed Manufacturing unit.
Accordingly the following requirements have to be fulfilled for the GMP for Premises and Equipments used in the Manufacturing Unit :
1) Location and Surrounding : The Manufacturing premises shall be located in an hygienic, clean and open area away from open sewage, open drainage, public lavatory and away from such factories which produce a lot of smoke, dust and fine particles of impurities to avoid the risk of contamination with the Drugs being Manufactured in the premises.
2) Building and Premises : The premises meant for the Manufacturing process should be Planned, Designed and Constructed in such a manner that it is well built, with smooth flooring, ceiling and well painted walls provided with different sections in an orderly manner to prevent cross mixing of workers or cross mixing of ingredients, samples, prepns. etc. Building shall be constructed as per the Sanctioned plan approved by concerned licensing Authority having different Sections / Rooms as follows neatly constructed without any cracks, fissures etc. to prevent insects, pests, birds etc.
a) A Separate Room with Furniture for the person in charge and other workers
b) A Store Room for Raw materials / Bulk Drugs
c) A washing and cleaning section
d) Separate Manufacturing sections for each type of formulations
e) Analytical section
f) Packing and labeling section
g) A Store Room for finished products
h) A Separate Section for Manufacturing sterile preparations provided with Air Conditioning and fitted with HEPA filters.
i) Separate Rest Rooms for either Sex.
j) The entire Building should be well ventilated, properly maintained, cleaned every day in the morning before manufacturing process and again in the evening before closure.
3) Ware House: A separate ware house should be provided in the premises only for keeping the Bulk Drugs raw materials etc. with a stock register and a person in charge to it (to be explained in detail) 4) Water supply: Pure and Good quality drinking water should be provided throughout the Manufacturing plant.
5) Disposal of Waste: waste produced in the premises should be disposed of properly after suitable treatment to make it harmless. 6) Health Clothing and Sanitation of Workers :
a) All the workers should maintain their health and if not doing well should not attend for the work.
b) They should be provided with proper uniform like White Clothing, Hand
Gloves, head gear, masks etc.
c) Separate Bath Rooms and toilets should be provided for either sex and
Where ever necessary the workers should have a bath and wear freshly cleaned and sterilized clothing.
d) All such rooms should be cleaned and sanitized at regular intervals on each day.
4). Medical services:
a) All the workers should be periodically checked for their health
b) Facilities of vaccination for epidemic and other communicable / contagious diseases should be provided for workers at regular intervals.
c) First aid kits should be provided in every section and workers should be trained for Emergency first aid treatment at the time of Accidents, Fire, Sudden Sickness of workers Etc., 5). Production / Manufacturing Area : should be such that there is no scope for cross mixing of workers or that of chemicals and Ingredients used during the Manufacturing process. Manufacturing Records as per Schedule ‘ U’ should be maintained.
6). Personnel :
a). Manufacturing process should be carried out only under direct Supervision of Expert Technical Staff i.e. “Approved Manufacturing Chemist”
b). Similarly, Analytical process of samples of Raw materials, Semi finished Drug and Finished Drugs should be carried out only under the direct supervision of Expert technical Staff i.e. “ Approved Analytical Chemist”). All other supporting staff and workers should also be well qualified and experienced in the Manufacturing, Analyzing, testing, Packing, Labeling etc. to ensure best quality output of Drugs or Cosmetics.
7). Quality Control Area (Analytical Area) : Separate Section should be provided for this purpose with ‘Approved Analytical Chemist” as its incharge. All records of Analysis should be maintained as per schedules U of D and C Act.
8). Quality Assurance :It includes the best quality assurance of using only best quality Bulk Drugs, Equipments, the quality of Drugs Manufactured with best quality packing materials like containers, bottles, labels etc. for which proper Records like “Batch Analytical Records” should be maintained.
9). Self-Inspection :Every Individual working in the Manufacturing unit should follow high standards in every step of Manufacturing process and evaluate himself, guide and help other colleagues also to improve and upgrade their capabilities in Manufacturing process. A Committee from outside the company should be constituted to inspect and evaluate the working capabilities of the staff and workers in the Manufacturing unit and submit their report for the evaluation and upgrading of workers.
10). Records :Systematic, proper and correct records like records of purchase of raw materials, Bulk Drugs, Equipments, vessels, Apparatus, packing materials, labels, Records of Manufacturing process including “Master formula, Charat”, “Batch Formula, Chart” Etc., as per Schedule ‘U’ including Analytical records, Stock Register, Sales records including copies of Invoices Etc. should be maintained.
11). Equipment’s :All the Equipments installed should bear a label with SOP’s (Standard Operating Procedures”) which should be under the supervision of a Supervisor or Mechanical Engineer, They should be cleaned, overhauled and kept under perfect working condition at all the times.
12). The List of Equipments to be Installed :The List of Equipments to be installed in a Manufacturing premises varies depending on the types of formulations or Drugs to be Manufactured in the premises. Accordingly Separate type of Equipments for Tablets, Capsules Ointments, Powders, Jellys, Semisolid Prepns, Separate Equipments for Sterile Manufacturing process etc., should be installed, Similarly separate sections should be provided for each type of formulations being Manufactured.
13). Sterile Manufacturing Section :Sterile Manufacturing Section should be separate and Air-conditioned. It should fulfill all the requirements mentioned under Schedule ‘M’ of D and C Act. (to be explained in detail).
14).Ultimate Motto of GMP :Ultimate motto or vision of ‘Good Manufacturing Practices’ to be followed under Schedule ‘M’ of D and C Act is to ensure the best quality of Drugs being Manufactured in a Licensed Manufacturing Unit of Drugs and Cosmetics. If each of the above mentioned practices are followed with other guidelines prescribed by WHO, a Manufacturer can definitely Produce / Manufacture the highest quality Drugs and Cosmetics
SCHEDULE ‘N’ OF DRUGS AND COSMETICS ACT:
Requirements to be fulfilled for the efficient Running of a ‘Dispensing Pharmacy’:-
1). Entrance: The front portion of the pharmacy shall bear the signboard as “Dispensing pharmacy” which should be clearly visible to the public
2). Premises: The premises meant for pharmacy should have at least 200 Sq of total area with a separated section of at least 80 Sqft. for dispensing room. It should be at least 9 feet height, well built, property ventilated, well painted clean and hygienic. Walls and floors should be smooth without any cracks or fissures.
3). Dispensing Section: This section with at least 80 sqft. area should be provided with separate racks for keeping Chemicals, apparatus, poisons, Books and journals. separate working benches should be provided for each pharmacist to dispense the Drugs.
4) Apparatus: The following apparatus should be provided in a Dispensing Pharmacy. Dispensing Balances, Chemical Balances, Electronic or Digital Balances, Beakers, funnels, Measuring Cylinders, Pipettes (1 ml, 2ml, 5ml, 10ml etc.) Tripod stands, Corks, Cork extractors, filter papers , Mortar and pestles ( both glass and porcelain) Ointment slabs , Ointment pots, Scissors, Spatulas, spirit lamps, gas connections, Thermometers, Distillation still, Pill making machines, Suppository moulds etc.
5) Books and Journals: The following Books and Journals should be provided in the Dispensing Pharmacy
a) Indian Pharmacopoeia (I.P) (latest edition)
b) National formulary of India (latest edition)
c) Drugs and Cosmetics act 1940 and its rules 1945 (including latest amendments)
d) Pharmacy act 1948
e) NDPS act 1985
f) Other related Acts
g) Various Pharmaceutical Journals
6) General Conditions
a) Dispensing of Drugs should be carried out only by the ‘Registered Pharmacist’ and his registration certificate should be prominently displayed in the premises.
b) He should always wear a clean and white Apron with a Name Plate and his Registration number.
c) He should store all the chemicals and apparatus properly and separately.
d) Poisons should be stored separately under lock and key and that Rack should be labeled clearly as “POISONS” in Red Colour.
e) He should always dispense the drugs with correct weighing, measuring, dispensing, filling, packing and labeling.
f) The label should bear the name of the Patient, Age, Sex, Name of the prescriber , Name and quantity of the Drug, date of dispensing, dose and directions for use.
g) He should dispense the drugs only on the prescription of an R.M.P.
h) He should maintain a record of all transactions including purchase invoices, Sales Bills, Stock Register etc.
i) He should update himself with modern technologies of Dispensing.
j) He should follow any other conditions mentioned in the licence or under D and C Act 1940.
SCHEDULE ‘Y’ OF DRUGS AND COSMETICS ACT
Schedule ‘Y’: It consists of the conditions and guidelines to be followed for carrying out the Clinical Trials on Newly Invented Drugs and also for New Drugs Imported for Sale in India. Introduction: A large Number of Pharmaceutical Industries, Research Organisations and Educational Institutions are carrying out Research work to find / invent a New Drug for a number of Diseases and an example is the latest Deadly disease Covid-19, or Corona Virus 19 and such Research work is called as Clinical Research which is normally carried out on Animals only and it is also called as pre-clinical Trials. It is not carried out on Human Beings. By conducting preclinical Trials, we can assess feasibility, safety, efficacy, minimum dose tolerance, maximum dose tolerance, virulence, side effects, Adverse reactions etc. of a Drug. If it passes all the tests and protocols of preclinical Trial, then Clinical Trials are commenced on Human Beings in different Phases as explained below. Pre-Clinical Trial is considered as Phase – 0
Permission to be obtained for conducting Clinical Trials:
Application in form No 12 for obtaining a Test Licence (TL) should be submitted to the Drugs controller General of India along with necessary information, Approvals from Institutional Ethics Committee, CDSCO i.e. Central Drugs Standard Control Organisation (Directorate General of Health Services, Ministry of Health and Family Welfare). Information to be provided in the application are mentioned below:
1) Full details of the Drug and when exactly it was invented
2) Whether already patented or not,
3) If patented, name and address of the patent holder, his Approval for further studies
4) Full details and protocols carried out during preclinical Trials including the reports, Suggestions etc. made
5) Names and addresses of Sponsorer for Clinical Trials to be carried out.
6) Names, Full Qualification, experience etc. of the main Clinicians and main investigating Clinicians conducting Clinical Trials.
7) Names and addresses of Institutions where Clinical Trials are proposed to be conducted.
8) Names of the Investigators, their qualification and experience.
9) Data Sheets to be used for the purpose of Clinical Trials, for different phases.
10) Prescribed consent formats of patients and Relatives.
11) Declaration by the main Sponsorer and that of the Head of the Institution where clinical Trials are to be carried out.
12) Any other information as required by the Licensing Authority.
13) Phase - 1 Clinical Trial data conducted in other countries should also be enclosed for such Drugs which are imported from other countries or else permission for Phase - 1 Clinical Trials itself will not be issued by the government. Whereas Drugs invented in India only permission that is Test Licence (T.L) is issued for Phase - 1 also permission in Licence in Form No. 11 shall be issued to the Applicant for conducting clinical Trials under different phases as follows.
Phase - I (Human Clinical Pharmacological Tests) :-
Phase - II (Explanatory Trials) :
Phase - III (Confirmatory Trial) :
If the Drug is already approved and marketed in other countries:
SALE OF DRUGS:
Sale of Drugs is classified in to four types as follows:
1) Wholesale of Drugs
2) Wholesale of Drugs from Vehicles (vendor’s Licence)
3) Retail sale of Drugs
4) Restricted Sale of Drugs (Restricted licence)
I). Wholesale of Drugs :
It is the process of sale of Drugs by a licenced Manufacturer or Distributor or Dealer to a licenced Retailer or Hospitals or Charitable Institutions or Research organisationsor to Registered Medical Practioners.
The following types of Licences are issued for the purpose of wholesale of Drugs.
a) Licence in form No 21-B for the wholesale of Schedule C and C1 Drugs.
b) Licence in form No 20-B for the wholesale of Drugs other than Schedule C, C1 and ‘X’, Drugs.
c) Licence in form no 20-G for the wholesale of Schedule ‘X’ Drugs.
1) Any person who wishes to have a wholesale distribution or dealership should obtain the above types of licences from the licensing authority on submission of applications in prescribed forms along with the prescribed fee and necessary documents including the information required for obtaining the Licences.
2) If the licensing authority is satisfied of all the conditions being fulfilled by the applicant shall issue such wholesale licences in the prescribed forms to the applicant.
3) On obtaining the licences, the licencee can start the wholesale distribution of Drugs from his licenced premises.
4) He should purchase the Drugs only from the licenced manufacturer or licenced stockist and store them properly in an orderly manner.
5) He should neither purchase nor sell the Drugs which are prohibited to be imported or manufactured or sold.
6) Drugs should be distributed /sold only under the supervision of a “Competent person” (“Competent Person” is the one who has completed at least an S.S.L.C. with a minimum of 3 years experience in wholesale or retail sale of drugs).
7) He should sell the Drugs only to the licenced retailers, hospitals, nursing, homes, Charitable Institutions and R.M.P’S
8) He should maintain all the records, invoices, bills and other related documents at least for 3 years and produce them whenever demanded by a Drugs inspector or licensing authority.
9) He should allow the Drugs inspector to inspect the premises, stock of Drugs and the records maintained by him.
10) He should allow the Drugs inspector to take the samples of Drugs to send them for analysis to a Govt. Analyst.
11) He should maintain separate storage facility, records, invoices and related documents for Schedule ‘X’ Drugs ( to be explained).
12) He should also fulfill any other conditions mentioned in the licences or mentioned under D and C act.
13) He should also maintain an inspection book in Form no. 35 issued by the Licensing Authority in which the Drugs Inspector should enter his observations during inspection
II) Wholesale of Drugs from vehicles ( Vendor’s Licence)
It is the process of distribution of Drugs through licenced vehicles to the dealers, retailers, nursing homes and R.M.P’S.
The following types of Licences are issued for this type of Distribution of Drugs
a) Licence in form no 23-BB for the wholesale of Schedule ‘C’ and ‘C1’ Drugs.
Licence in form no 20-BB for the wholesale of Drugs other than Schedule ‘C’ ‘C1’ and ‘X’.
All the conditions prescribed under wholesale of Drugs also apply for wholesale of Drugs from vehicles under vendor’s licence. However licence for the wholesale of Schedule ‘X’ Drugs is not issued under this category. III. Retail Sale of Drugs ( Chemist and Druggist)
It is the process of retail sale of Drugs by a licenced retailer to the customers, Hospitals, nursing homes and R.M.P’S and require the services of a “Registered Pharmacist”.
Following types of licences are issued for the retail sale of Drugs
a) Licence in form No 21 for the retail sale of Schedule ‘C’ and ‘C1’ Drugs.
b) Licence in form No 21 for the retail sale of Drugs other than Schedule ‘C’ ‘C1’ and ‘X’.
c) Licence in form no 20-F for the retail sale of Schedule ‘X’ Drugs.
Any person who wishes to start a retail sale business i.e. a Chemist and Druggist store should fulfill the following conditions for obtaining the retail licenses:-
1) A premises with not less than 120 Sq. feet area should be provided ( either owned or leased).
2) It should be properly painted and furnished with Racks having glass shutters and to be maintained cleanly.
3) It should be provided with a refrigerator for storing the Drugs which are to be stored below 20° C.
d) Either the applicant should be a ‘Registered Pharmacist’ or he should appoint a ‘Registered Pharmacist’ to supervise the sale of Drugs.
e) He should submit applications in the prescribed forms along with the prescribed fee and necessary documents to the licensing authority at least one month prior to the commencement of the business.
f) On receiving the applications and after the inspection of the premises and verification of the documents submitted by the applicant, if the licensing authority is satisfied, shall issue the licences in the prescribed forms within one month of receiving the applications.
On obtaining the licences the licencee can commence the business of retail sale of different categories of Drugs and fulfill the following conditions of retail licences.
1) All the Licences should be prominently displayed in his premises.
2) He should purchase the Drugs only from the licenced Manufacturers or distributors.
3) He should neither purchase nor sell the Drugs which are prohibited to be sold.
4) All the types of Drugs purchased should be stored properly and systematically in an orderly manner.
5) He should not sell “physician samples” Drugs meant for “free of supply” at Government Hospitals or charitable institutions and the Drugs which are date expired.
6) A separate Rack should be provided for keeping the veterinary Drugs.
7) A separate rack with lock and key should be provided for storing Schedule ‘X’ Drugs.
8) All types of Drugs should be sold only under the supervision of “Registered Pharmacist”.
9) All the Drugs specified under Schedule ‘H’ and ‘ X ‘should be sold only on the prescription of a ‘Registered medical practitioner’.
10) No prescription should be dispensed repeatedly unless required to do so by the prescriber.
11) The Drugs prescribed by R.M.P should not be substituted or altered or changed with an alternative Drug unless approved by the prescriber.
12) All the Drugs should be sold only with a invoice or a bill in which name of the patient, name of the prescriber, names and quantities of Drugs, their Batch Nos, Date of expiry and name of the of the Manufacturer, cost of the Drug, total amount etc. should be entered, signed by the “Registered Pharmacist” and issued to the customer.
13) All the purchase invoices, sales bills and other related documents should be maintained by the licencee for at least 3 years and produced whenever demanded by the Drugs Inspector or licensing authority.
14) All date expired Drugs should be removed from the stock, entered in a separate register and returned to the distributor for replacement
15) Separate stock register, purchase invoices, and sales bills should be maintained for Schedule ‘X ‘Drugs.
16) Inspection Book in form No 35 should be maintained by the licencee.
17) Drugs Inspector or any authorized officers of the Drugs Control Department should be allowed to Inspect the premises.
18) If the Drugs inspector wishes to collect the samples of Drugs to send them for analysis and assay, should be allowed to collect such samples for which he can collect the cost and issue a Bill.
19) If the Drugs inspector orders to stop the sale of a certain batch of drug he should do so until the officer allows him to sell that particular Batch of Drug
20) Drugs inspector should enter all observations he has made during inspection in “Inspection Book No. 35” maintained by the licencee
21) Licencee should inform any change in the name of ‘Registered Pharmacist’ with in one month of such a change and get the new name entered in his licences.
22) Licencee should get the licences renewed within the due date ( at least one month before the date of expiry.
23) He should also follow any other conditions of his licences or the conditions mentioned under D and C act
24) Licenses are liable to be suspended or canceled if the license has committed any offence under the retail license
IV). Restricted Sale of Drugs (Restricted licence):
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It is a type of licence issued for the retail sale of only certain categories of drugs and does not require the services of a ‘Registered Pharmacist’.
Following types of Licences are issued under ‘Restricted Licence’
a) Licence in from No 21-A for the sale of Schedule ‘C’ and ‘C1’ Drugs
b) Licence in from No 20-A for the sale of Drugs other than Schedule ‘C’, ‘C1’ and ‘X’
Any person who wishes to sell the drugs under ‘Restricted Licence’ should obtain the above mentioned licences from the Licensing Authority on submission of an Application in prescribed form and the prescribed fee.
Only certain types of Drugs namely general Drugs and household remedies like Vicks, Amurtanjan and certain OTC drugs are permitted to be sold under this licence.
All the conditions mentioned under the licenses should be followed by the license.
LABELING REQUIREMENTS OF DRUGS
I. General Labeling Requirements:
The Following particulars have to be printed on the Labels of all the type of
Drugs Manufactured under D and C Act :-
1) Trade name of the Drug in Capital Letters
2) Generic name of the Drug in Capital Letters
3) Name of the Official Book of Standards followed if any like I.P, B.P, USP Etc.
4) Quantity of the Drug in weight or Volume.
5) Names of each ingredient present in the Drug
6) Net content in Weight or Volume or Number of units of each ingredient
7) Manufacturer’s License No.
8) Batch No of the Drug
9) Date of Manufacture
10) Date of Expiry of the Drug
11) Storage Conditions
12) Directions for use
13) MRP to be printed clearly including all taxes
14) Manufacturer’s Name and Address
15) Warning : Keep the drug away from the reach of Children
II. Specific Labeling Requirements: Apart from the above General labeling
requirements, certain specific labeling requirements have to be printed on the
Labels depending on the type of Drugs Manufactured as mentioned below:
A). For Schedule ‘G’ Drugs :
Warning to be used only under supervision and
Directions of R.M.P.’
B). For Schedule ‘H’ Drugs :
1. Symbol RX to be printed in Red Colour on the top corner of the label
2. “Schedule ‘H’ Drug, Warning: to be sold by retail only on the prescription of an RMP (in a box column)
C). For Schedule ‘X’ Drugs:
1. Symbol XRX to be printed in Red colour on the top corner of the label.
2. The words, “Schedule ‘X’ Drug Warning: “to be sold by retail on the prescription of “Registered Medical Practitioner”.(in a box column).
D). For Lotions, Liniments, Suspensions
1. “Contents to be Shaken well before use”
2. In Capital letters “FOR EXTERNAL USE ONLY” E). For Non Sterile Sutures and Ligatures:
1. What type i.e. whether it is a ‘Suture’ or a ‘Ligature”
2. Gauge of it, in No’s like 0/3, 0/4, 1,2,3,4,5, etc. (it is an indication of diameter or thickness of Suture or Ligature
3. Warning : “Non Sterile Ligature”, “to be sterilized properly before surgery” or “Not to be used on Human Body for operation unless properly sterilized”. F). Ophthalmic Preparations (Eye Drops, Eye Lotions):
Note:
1) “To be used within one month after its opening”
2) “Not for Injection”
3) “For External use only”
4) Warning: “If irritation persists or increases, discontinue its use and consult the Physician.
5) “Do not touch the dropper tip to any surface as it may contaminate the Solution. G). For Veterinary Drugs:
1) Symbol of the head of a Domestic Animal like Cow, Dog, Etc to be printed at the top corner of the label.
2) Warning: “NOT FOR HUMAN USE”
3) “FOR THE TREATMENT OF ANIMALS ONLY” H). For Hair Dyes:
1) Caution: This product contain ingredients which are likely to irritate the skin or may be harmful for skin, Therefore apply a small quantity on your skin and observe for 15 minutes before applying”. 2) It should not be applied on eye lashes or eye brows as it may cause blindness. 3) “POISON”. 4) “FOR EXTERNAL USE ONLY”. 5) “DO NOT USE IT FOR CHILDREN TO DYE THE HAIRS” (Optional) Write Specimen labels for the following Drugs:
1) Insulin I.P. Injection: 10 ml X 1 No, Strength: 80 units per ml
2) Ciplox Capsules: 1 Strip of 10 Capsules containing 500 mg of ciprofloxacin each.
3) Aten USP tabs : 10 strips of 10 tablets each containing 50 mg of Atenolol USP
4) HAIR DYE: 50ml
5) Phenobarbitone Sodium tablets B.P: 1 strip of 10 tablets each containing 90 mg of Phenobarbitone Sodium B.P.
6) Betnesol–N. Eye drops: 5ml each ml containing 50 mg of Betamethasone and 10 mg of Neomycin.
Specimen Label for 10 strips of 10 tablets each containing atenlol 50mg USP
Various administrative bodies constituted / appointed under the Act:
For the purpose of efficient implementation and administration of the D and C Act, the following agencies have to be constituted by the Central Government / State Governments.
I. Advisory Bodies:
1. Drugs technical advisory board (DTAB)
2. Drugs consultative committee(DCC)
II. Analytical Bodies:
3. Central Drugs laboratory (CDL)
4. State Drugs testing laboratories
5. Government analyst
III. Executive Bodies:
6. Central Drugs control Department Licensing Authorities
7. State Drugs control Department
8. Drugs Inspector
I. ADVISORY BODIES:
Drugs Technical Advisory Board Constitution and Functions of Drugs Technical Advisory Board (DTAB)
of D and C act 1940 for a term of 3 years each time; It is constituted with the following elected, Nominated and Ex- officio members.
A. Elected Members:
1) One person to be elected by P.C.I from amongst the teachers in pharmacy or pharmaceutical chemistry or pharmacognosy of an recognized pharmacy college or university
2) One person to be elected by M.C.I from amongst the teachers in medicine of a recognized medical college or university.
3) One pharmalogist to be elected by the governing body of Indian council of Medical Research (ICMR).
4) One person to be elected by Indian Pharmaceutical Association (IPA).
5) One person to be elected by Indian medical association from amongst its members (IMA).
B. Nominated Members: (by Central Government)
6) Two persons to be nominated from amongst the Drugs controllers of all the States.
7) One person to be nominated from the pharmaceutical industry.
8) Two Government analysts to be nominated from amongst Government analysts of Central Drugs laboratory and State Drugs testing laboratories. Ex- Officio Members:
9) The director general of the health services (Central health Department) who shall be the chairman of the board.
10) The Drugs controller general of India of Central Drugs control Department
11) Director of the Central Drugs Laboratory (CDL) Kolkata
12) Director of the Central Research institute, Kasouli
13) Director of the Central Drugs Research Institute, Lucknow
14) Director of the Indian veterinary Research Institute, Izatnagar
15) President of the pharmacy council of India (PCI)
16) President of the Medical council of India (MCI)
Members hold the office for a period of 3 years, they are eligible for re-nomination and reelection, any member can resign during the term from his membership. Any vacancies of members created due to resignation or death can be filled up only for the remaining period. the members can constitute an executive committee and subcommittees for varies purposes. The Board can appoint a registrar or secretary and sufficient no of officials for day to day functioning of the Board and fix their salaries.
Functions:
1) To advise Central/ State Governments on various technical matters arising out the administration of D and C act:
2) To advise / suggest about any amendments to Drugs and Cosmetics.
3) To carry out any other functions entrusted to it by the Central Government related to D and C act.
Drugs Consultative committee: (D.C.C)
The Drugs consultative committee is constituted by the Central Government under section 7 of the D and C act . it is constituted with the following members :
1) Two representatives of the Central Government to be nominated by the Central Government.
2) One representative of the State Government to be nominated by the concerned State Governments
Functions of the Drugs Consultative Committee:-
1) To advise /suggest the Central Government and the State Governments and also D.T.A.B, about ensuring uniformity in enforcement of the Drugs and Cosmetics act entrusted and its rules.
2) To carry out any other functions entrusted to the act by the Central Government which are related the Drugs and Cosmetics.
II. ANALYTICAL BODIES:
1) Central Drugs laboratory (C.D.L): it is established by the Central Government under section 7 of D and C act 1940. It is established in Kolkata and consists of a Director and sufficient no of officers for the laboratory.
Functions of the CDL:-
a) To carry out analysis of samples of Drugs and Cosmetics sent to it by the customs officers.
b) To carry out analysis and assay of samples of Drugs sent to it by the courts.
c) To carry out any other functions entrusted to it by the Central Government.
The samples of vaccines sera and others biological prepns are analyzed at Central research institute, Kasauli on behalf of C.D.L
The samples of polio vaccines are analyzed at polio vaccine testing laboratory of Central research institute on behalf of C.D.L
The samples of Veterinary Drugs are analyzed at Indian Veterinary research Institute, Izatnagar on behalf of C.D.L.
The samples of mechanical contraceptives are analyzed at the Central
Indian pharmacopeia laboratory, Ghaziabad on behalf of C.D.L
The samples for Human Blood and plasma etc. are analyzed at the National Institute of Virology – Pune
The samples for analysis should be sent in sealed packing by Registered post to the concerned Directors of the laboratories. officers in charge of the lab shall receive the samples, check for the sealed packings and carry out the analysis and assay of the samples as per the protocol, and submit the report to the director, who after checking the report, puts his signature alsoand send the report confidentially by Registered Post to the person who has sent the sample for analysis. Such a report is considered as official and authentic by the court of law as per the act.
2) State Drugs Testing Laboratories:
Each and every State Government shall establish the State Drugs testing laboratories or Government Drugs testing laboratories with a Director or a superintendent and sufficient no of Government analysts to the laboratory. Private Drugs testing laboratories are also permitted to be established under the act. The main function of the State Drugs testing laboratory is to carry out the analysis and assay of samples of Drugs and Cosmetics sentto it by the Drugs Inspectors and submit its report to the Inspectors. It can also carry out the analysis of Drugs sent to it by any individuals or manufacturing units on payment of the prescribed fee and submit its report to the concerned persons. such analysis and assay of the samples of Drugs and Cosmetics received by the laboratory is carried out by the Government Analysts of the laboratory.
3) Government Analysts:
A Government analyst is appointed by the Central Government or State Government under section 20 of the D and C act, for the purpose of analyzing the samples of Allopathic Drugs and cosmists and under section 33-F for analyzing and testing the samples of Ayurvedic, Unani and siddha system of medicines. A Government analyst appointed should not have any financial interest or business of his own in Import, manufacturing and sale of Drugs and Cosmetics or other types of private business. A Government Analyst is a ‘Public Servant’ Under Section 21 of the Indian Penal Code (IPC) and all terms and conditions prescribed for a ‘Public Servant’ shall also apply to Government Analyst.
I. Qualifications prescribed for the appointment of a Government analyst:
Following are the Qualifications prescribed for the Appointment as Government Analyst:-
1) A Graduate / Degree in pharmacy or Medicine or Science of a recognized college / University with at least 5 years of post graduate experience in analyzing and testing the samples of Drugs and Cosmetics under a Government analyst or under the Head of in approved Drugs testing laboratory.
OR
2) A Post Graduate Degree in Pharmacy or Medicine or Science of a recogsnised college / University with at least 3 years of post graduate experience in analysing and testing the samples of Drugs and Cosmetics under a Government analyst or under the head of an approved Drugs testing laboratory
OR
3) An associate ship Diploma of the Institution of chemists (India) with “Analysis of Drugs and Pharmaceuticals” as one of the subjects studied with not less than 3 years of experience in the analysis and assay of Drugs and Cosmetics under a Government analyst or under the Head of an approved Drugs testing lab.
OR
4) For the purpose of analyzing and testing the samples of veterinary Drugs, a person should have any one of the above mentioned Educational Qualifications with not less than 3 years to5 years of experience respectively in analysing and testing the samples of veterinary Drugs.
OR
5) For the purpose of analyzing and testing the samples of biological and special prepns like vaccines, sera etc. mentioned under schedule C and C1, of D and C Act, a Person with any one of the above Educational Qualifications with not less than 3 Yrs to 5 yrs respectively of experience in testing and analyzing such samples under a Government analyst or under the head of an approved Drugs testing laboratory.
II. Duties of a Government analyst:
Following are the duties of a Government Analyst
1) To analyze and test the samples of Drugs and Cosmetics received by him form Drugs Inspector or other persons and forward the report to the concerned persons who have sent the samples to him.
2) To carry out any Research work and publish the articles of Research after obtaining permission from the Director or the Head of the Drugs testing laboratory.
3) To carry out any other duties entrusted to him by his superior officers related to testing and analyzing, different types of Drugs and Cosmetics.
-:Thank You:-
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