Unit-1 DRUGS AND COSMETICS ACT 1940 AND ITS RULES 1945

 

Introduction:

Since the days of introduction of Allopathic Drugs in the Indian market by the early 20th century, the demand for these modern system of Drugs (Allopathic) went on increasing exponentially throughout the country because of their excellent medicinal properties and immediate cure for various types of diseases like malaria, cholera, plague, typhoid etc. prevailing commonly in those days. This demand had lead the country to be flooded with all sorts of adulterated and substandard Drugs as there were no strict Rules and regulations to control such unhealthy practices. The British Government was then forced to constitute a committee which was constituted under the chairmanship to CL R.N. Chopra in 1929 and named it as “CL R.N. Chopra committee”. The committee submitted its report in 1931 in which it Stated the immediate necessity of implementing stringent rules and regulations on the Import, Manufacture and sale of Drugs. In the meantime usage and demand for Cosmetics also increased to a great extent which are also likely to cause side effects or even danger to the life of people using Cosmetics making it necessary to bring them also under the preview of Drugs.

Therefore an act in the name of “Drugs and Cosmetics Act” was implemented by the Central Government in the year 1940 and its rules in 1945 in order to have a stringent control over the Import, Manufacture and sale of all types of Allopathic Drugs and Cosmetics but also Ayurvedic, Unani, and homoeopathic system of Drugs. The act has been amended several times during the course of 80 years since its implementation till date so as to ensure the Import, Manufacture and supply of only the best and standard quality Drugs to a common man. However the Act was actually enforced from 1947 onwards throughout the country.

Definitions:

1) Drugs: are defined to include all the types of medicines used for diagnosis, prevention, cure and mitigation of any types of diseases in human beings or animals and meant for either internal or external use including mosquito repellents, empty gelatin capsules, Medical devices used for diagnosis or treatment and any other substances used for altering the structure and functions of human body as well as vermicides (used to kill or expel worms). 

2) Cosmetics: are defined to include any articles or substances intended to be rubbed, poured, sprinkled or sprayed or applied or introduced in to any part of the human body for the purpose of cleansing, beautifying promoting attractiveness or for altering the appearance of any part of the human body. 

3) Patent and Proprietary Medicines: are defined to include the medicines which are prepared or Manufactured according to a formula of his own by a Manufacturer approved by the Central Government. and which are not found in any official Books of standards like I.P, B.P., USP etc., (However the formula should be disclosed to the Central Government). 4) Adulterated Drugs : are defined to include the Drugs which are already decomposed, putrid or filthy, or which have been prepared under insanitary / unhygienic conditions which might have been contaminated or the container is poisonous or contains any harmful or toxic substance which may be injurious to health

5) Misbranded Drugs : A Drug is deemed to be misbranded if it is coloured, coated, powdered, polished, packed and labeled so as to conceal its quality and made to appear as a better quality Drug even though it is substandard, or packed and labeled with the false claim of its quality, or strength in order to mislead the public.

6) Spurious Drug :A Drug which is Imported under the name of another original Drug or which is Manufactured and labeled in the name of another original Drug, or a substitute or an imitation of another Drug or a Manufacturer in order to deceive or mislead the public.

 7) New Drug :is the Drug allowed to be released in the market for sale for the time being or temporarily which is not yet officially recognized or declared by the authorities as fully safe for use in human beings or animals for diagnosis or treatment of any diseases in human beings or animals. 

8) Drugs Inspector : is a person who is appointed by the Central or State Governments under section 21 of the D and C Act for the purpose of Inspecting Manufacturing and sales premises of Allopathic Drugs and under section 33-G of D and C Act for Inspecting Manufacture and sales premises of Ayurvedic, Unani, Siddha and Homeopathic Drugs. 

9) Government Analyst: is a person who is appointed under section 20 of the D and C Act by the Central Government or State Government for testing and analysing the samples of Allopathic Drugs and under Section 33-F of D and C Act for testing and analysing the samples of Ayurvedic, Siddha, Unani and Homeopathic system of Drugs. 

10) Manufacture: It is the process of preparing or manufacturing or making, altering, finishing, polishing, packing and labeling of any Drugs or Cosmetics meant for sale in a licensed premises except compounding and dispensing of Drugs.

 11) Loan License: It is a type of Manufacturing license issued to a person who does not have his own premises for the Manufacture of Drugs or Cosmetics but wishes to Manufacture in an already licensed manufacturing premises.

 12) Repacking License: It is a type of license issued for the process of breaking up any Drug from a bulk container and transferring into small containers, packing, sealing and labeling for the purpose of sale and does not include compounding and dispensing of Drugs. 

13) Drug Store :It is a licensed premises where only certain restricted type of Drugs (House hold remedies) are allowed to be sold and does not require the services of a Registered Pharmacist.

 14) Chemist &Druggist: It is a licensed premises where all the types of Drugs and Cosmetics can be sold by retail sale and requires the services of a Registered Pharmacist. 

15) Pharmacy (Dispensing Pharmacy): It is a licensed premises where the Drugs are actually compounded and dispensed for sale on the prescription of an R.M.P. and requires the services of a Registered pharmacist. 

16) Registered Medical Practitioner: is a person who holds an approved or recognized qualification in Allopathic, Ayurvedic and Unani or Homeopathic system of medicine or Dental or Veterinary medicine who is for the time being Registered in the State councils of the concerned system of medicine and practicing in the concerned State. 

17) Wholesale of Drugs: It is the process of sale of Drugs by wholesale either by licensed Manufacturer or distributor.

Import of Drugs

 Import of Drugs is classified in to three types as follows:

I. Classes of Drugs Prohibited to be Imported.

II. Classes of Drugs Permitted to be Imported under a License

III. Classes of Drugs Exempted from Import Regulations.

I. Classes of Drugs prohibited to be Imported: the following classes of Drugs are prohibited to be Imported in to India.

1) Any Drug which is not of “Standard Quality” as mentioned under D and C Act.

2) Any ‘Misbranded Drug’ as defined under D and C Act.

3) Any ‘Adulterated Drug’ as defined under D and C Act.

4) Any ‘Spurious Drug’ as defined under D and C Act.

5) Any ‘Patent and Proprietary Medicine’, the true formula of which is not disclosed or displayed in the label or packing of the Drug.

6) Any Drug which directly claims to cure any diseases mentioned under schedule ‘J’ of D and C Act.

7) Any Cosmetic containing an ingredient or a formula which is unsafe or harmful for use.

8) Any Drug which has been specifically mentioned by the Central Government as a ‘Banned Drug’ in India in the interest of public safety.

However Central Government may also allow a specific Drug to be imported, which is otherwise normally prohibited to be imported, with certain conditions prescribed on its Import.

II).Classes of Drugs Permitted to be Imported under a License or Permit

The following classes of Drugs are allowed / permitted to be imported in to India. Only on a license or permit issued by the licensing authority.

1) Classes of Drugs specified under Schedule C and C1, (Import License in Form No. 10).

2) Classes of Drugs specified under schedule X, ( Import License in Form No. 10-A)

3) Classes of Drugs meant for Examination, Test or Analysis only

(Import License in Form No. 11)

4) Drugs meant for personal use only ( Permit in Form No 12 – B)

5) Any ‘New Drug’ as defined under D and C Act. ( Permit in Form No 12)

III. Classes of Drugs Exempted from Import Regulations : 

The following classes of Drugs are exempted from Import Regulations and can be Imported in to India without any separate license or a permit under D and C Act.

1) Drugs which are not meant for Medicinal use and accordingly labeled as ‘NOT FOR MEDICINAL USE’ in its labels and packing.

2) Condensed Milk Powders like ‘Lactogen’, ‘Nestle’ etc.

3) Milk substitutes like ‘Farex’, ‘Oats’, ‘Lactose’ and other cereal preparations.

4) Spices like ginger, pepper, cinnamon, clove, cardamom etc.

5) Drugs under transit through India from one country to other, provided both

Exporter and Importer have the proper Licenses/Permits from the concerned Countries.

Conditions to be followed under Import license or Permit

The following conditions have to be followed by a person under Import License:-

1) He shall obtain a license or a permit in the prescribed form from the Licensing Authority on submission of an application in the prescribed format and on payment of prescribed fee.

2) Licensee shall provide proper and sufficient storage facility including cold storage unit for the Drugs Imported by him.

3) He should purchase/procure the Drugs of ‘standard quality’ only from a licensed Manufacturer, Distributor or the Exporter of the originating country.

4) He should allow the customs officer of the port to inspect the consignment and to take samples if necessary to send them for Test and Analysis to a ‘Chemical Examiner’ of the Customs Department.

5) He should store the Imported Drugs in a proper and hygienic condition in his licensed premises only.

6) He should maintain a record of all the purchases and sales made of Imported Drugs including Invoices and Bills.

7) He should supply the Imported Drugs only to the licensed manufacturers or Distributors or Dealers. OR

8) He should utilize the Imported Drugs only for the purpose for which they have been imported.

9) He should maintain an Inspection Book in form No 35 as prescribed under D and C Act 1940.

10) He should allow the Drugs Inspector or any other authorized officers of the Licensing Authority (Drugs Control Department) to inspect the Premises, Imported Drugs, Records, Invoices, Bills Etc., to satisfy themselves that the Importer is following the conditions of Import License.

11) He should also allow the Drug Inspector to take any sample of an Imported Drug to send it to ‘Government Analyst’ for analyzing and testing so as to satisfy himself that the Imported Drug is of standard quality.

12) He should maintain a Separate Record of all the Drugs Specified under Schedule ‘X’ in which he has to enter the following information.

a) Name and quantity of each such Drug Imported.

b) Batch No.

c) Name and Address of the Manufacturer including his License Number.

d) Name and Address of the Exporter including his License Number.

e) Date of transaction of Import including the Date of Receipt of Stock. Date of sale.

f) Name, Address and License No of the person to whom the Imported Drug has been sold including a copy of Invoice/Bill.

g) A Separate Stock Register of all such Imported Drugs of Schedule ‘X’.

h) Name and signature of the person who has sold the stock of such Drugs.

i) Any other information as required under D and C Act. 

OFFENCES AND PENALTIES UNDER IMPORT OF DRUGS :

The following punishments/penalties may be levied for persons committing an offence under Import of Drugs.

1. If any person Imports any Adulterated, Substandard and Spurious Drug is punishable with an imprisonment up to 3 years and a Fine up to 5000 Rs on the first conviction and an imprisonment up to 5 years and a Fine up to 10,000 Rs on subsequent conviction.

2. If any person Imports any other prohibited Drug to be Imported is punishable with an imprisonment up to 6 months and a Fine of Rs. 500 on the First Conviction and an imprisonment up to 1 Year and a Fine up to Rs.1000 on the subsequent Conviction.

3. If any person Imports any Drug or a Cosmetic which is banned in India, or any other Drug specifically prohibited to be Imported is also punishable with an imprisonment up to 3 years and a Fine up to Rs. 5,000 on the First Conviction and an imprisonment up to 5 years and a Fine up to Rs.10, 000 on the subsequent Conviction.

4. All the Stock of Drugs and Cosmetics which have been Imported in respect of which an offence has been committed under Import Regulations are liable to be confiscated and disposed off according to the order of the Court.

MANUFACTURE OF DRUGS (Meant for sale)

Definition: It is the process of preparing, making, altering, finishing, ornamenting, packing, sealing and labeling of a Drug or a Cosmetic meant for sale excluding compounding and Dispensing of Drugs.

Manufacture of Drugs and Cosmetics is Classified in to three types as follows:

I. Manufacturing License

II. Loan License

III. Repacking License

I). Manufacturing License: These types of Licenses are issued for such persons who have their own land, premises, plants and equipments for the Manufacture of different types of Drugs and Cosmetics. (Leased premises are also allowed for Manufacturing Licenses)

Licenses: Under the above type of Manufacturing, the following types of Licenses are issued for different Categories of Drugs and Cosmetics as follows:

A) License to Manufacture Drugs Specified in Schedule ‘C’ and ‘C1’ (in form No. 28)

B) License to Manufacture Drugs Specified in Schedule ‘C’ ‘C1’ and ‘X’ ( in form No. 28B )

C) License to Manufacture Drugs other than Schedule ‘C’ and ‘C1’ (in form No. 25), (I.e. General Categories of Drugs, Schedule ‘H’ and Schedule ‘G’ Drugs)

D) License to Manufacture Drugs Specified in Schedule ‘X’ only (in form No. 25-F).

E) License to Manufacture Drugs meant for Examination, Test or Analysis only (In form No. 29)

II. Loan License:-

F).Loan License for the Manufacture of Schedule ‘C’ and ‘C1’ Drugs (in form No.28-A).

G). Loan License for the manufacture of Drugs other than Schedule ‘C’, ‘C1’, and ‘X’ Drugs. (In form No.25-A) 

III). Repacking License:

H). Repacking License for Repacking the Drugs other than Schedule ‘C’,’C1’, and ‘X’ i.e. for Repacking only certain types of Drugs and Chemicals ( in form No.25-B).

Procedure (Conditions) to be followed for obtaining Manufacturing Licenses:

General Conditions: The following procedure has to be followed for obtaining the Manufacturing Licenses to Manufacture Drugs meant for Sale.

1). Applications in the prescribed forms along with the prescribed fee and necessary documents have to be submitted to the Licensing Authority (Drugs Controller of the State) at least 3 months prior to the commencement of Manufacture.

2). The Building or the premises meant for the Manufacture should fulfill all the requirements mentioned under Schedule ’M’ of the D and C Act.

3). Applicant should provide the following information in his application:-

a) Name and residential Address of the Applicant and that of the Manufacturing point.

b) Names and Addresses of partners if it is a Partnership Firm.

c) Names and Addresses of Board of Directors if it is a Company.

d) Names, Qualification and experience of “Expert Technical Staff” (like that of person in charge of Manufacturing, person in charge of Testing and analyzing the samples of Drugs).

e) List of all the plants and Equipments being installed.

f) List of all the preparations (Drugs) proposed to be Manufactured.

g) Facilities provided for storage of Raw Materials, washing and cleaning of Apparatus, vessels etc., Manufacturing section, Analytical Section, Storage facilities for finished products, facilities provided for workers etc.

4). Separate Manufacturing sections should be provided for different types of formulations like tablets, Capsules, liquid orals, Parenteral Prepns. Etc.,

5). Section meant for Parenteral Prepns. should be Air Conditioned fitted with HEPA Filters ( to be explained in detail).

On receiving the applications, Licensing Authority shall depute a drugs Inspector to inspect the premises, plants and equipments installed and if everything is found satisfactory, shall issue the licenses in different forms for different categories of Drugs to be Manufactured in the premises. 

General Conditions of manufacturing License:

On obtaining the license to Manufacture the Drugs, the Licensee shall fulfill the following conditions.

1). Licensee shall follow “Good Manufacturing Practices” (GMP) only to the best of ability as mentioned under ‘Schedule M’ of D and C Act.

2). He shall appoint all the necessary workers/staff to the Manufacturing unit including properly qualified, trained and experienced ‘Expert Technical Staff’ to be in charge of Manufacturing and Analytical Section.

3). He shall purchase the best quality Raw Materials ( Bulk Drugs) only from Licensed Manufacturers or Distributors and Stored in a Separate Room where three sections are provided namely for

a) “Stock Received and Stored”

b) “Stock tested and Rejected”

c) “Stock tested and approved”, which are labelled accordingly.

4). Only the Stock of Raw Materials which are “Tested and Approved” in the Analytical Lab of the Manufacturing unit should be used for manufacture.

5). A “Batch formula Chart” should be prepared first for the Drug to be Manufactured which should contain the Name of the Drug, the formula, total quantity being Manufactured, Batch No., Date of Manufacture, Expected yield, procedure to be followed for Manufacture, precautions to be taken during Manufacture, and any other information including Signature of the person in charge of Manufacturing as per Schedule ‘U’ of the D and C Act. “Batch formula Chart” shall be prepared by referring the “Master formula chart” of a Drug.

6). All the workers should wear fresh and cleaned clothing including Aprons or uniforms who should maintain strict hygienic conditions during the Manufacture.

7). All the Equipments used should have SOP’s (Standard Operating Procedure) and should be checked and cleaned at regular intervals and kept in perfect working condition.

8). The Manufacturing process, finishing, packing and labeling should be carried out systematically without cross contamination or cross mixing of ingredients, Chemicals etc., and under the supervision of “Approved Manufacturing Chemist” (Export Technical Staff).

9). Samples from semi-finished and finished Drugs should be tested and analyzed at regular intervals during production to ensure the quality and strength of the Drug.

10). “Reference Samples” of each batch of the Drug should be preserved for at least 3 years and submitted to licensing authority whenever demanded.

11). If any batch of a Drug is found to be substandard during or after the Manufacture, the entire batch of Drug should be destroyed.

12). Drug Inspectors or any other Authorized Officers of the Drugs Control Dept. should be allowed to inspect the premises.

13). An Inspection Book in form No.35, should be maintained by the licensee and the Drug Inspector has to make/write his observations in the Inspection Book during the process of Inspection.

14). Drug Inspector should be allowed to take the samples of Drugs from the Manufacturing unit to send them for analysis to the “Govt. Analyst”.

15). If any batch of a Drug is reported to be of substandard quality by the Government Analyst, that batch of Drug should be immediately withdrawn from the market and destroyed.

16). “Analytical Chemist” in charge of the Analytical Lab of the Manufacturing Unit should carry out the analysis and assay of the samples of Raw Materials (Bulk Drugs), Semi finished products and finished products and maintain a Record of all such analytical Reports as per Schedule ‘U’ of the Drugs and Cosmetics Act.

17). All types of Manufacturing licenses should be prominently displayed in the premises and should be got renewed before the date of expiry of Licenses.

18). Stock Registers, purchase invoices, sales invoices and other documents relating to the Manufacture and sale of all the Drugs should be maintained properly and produced before Drugs inspector or the licensing authority whenever demanded.

19). Manufacturer should sell the Drugs only to the Licensed distributors, dealers or retailers.

20). Manufacturer should also follow any other conditions mentioned in the licenses or mentioned under D and C Act 1940.

Additional Conditions to be fulfilled for the Manufacture of Schedule ‘X’ Drugs

1) A separate License for the Manufacture of Schedule ‘X’ Drugs should be obtained from the Licensing Authority (in form no. 25-F).

2) A separate account /Statement / Register of all the bulk Drugs of schedule ‘X’ purchased, stocked, tested, Manufactured and sold should be maintained comprising the following details:-

a) Name, Address and License No. of Bulk Drug Manufacturer/ Dealer from whom it is Purchased

b) Names and quantities of each Bulk Drug/ raw Materials purchased including the date, invoice no etc. and should be stored separately

c) Quantity of Bulk Drugs used for Manufacture for each batch

d) Opening stock and closing stock of each Bulk Drug in the stores

e) Stock of finished products obtained with their date of Manufacture, Batch No. etc. which should be stored separately.

f) Stock of finished products sold or supplied to distributors, Dealers, Retailers, Hospitals, Nursing homes etc. with copies of invoices, date of sale etc.

g) Names and signatures of persons in charge of the stores, Manufacturing section, analytical section, finished products store etc. should be maintained separately.

3) The Entire process of Bulk Drugs of Schedule ‘X’ Purchased, manufactured, stored and sold should be intimated to the licensing authority with a detailed report once in every three months.

4) Finished products of schedule ‘X’ Drugs will have to be labeled accordingly as per the labeling requirements mentioned under D and C act.

Loan license

1) Loan licenses for the Manufacture of Drugs meant for sale are issued to such persons who do not have their own Premises / Building but wishes to Manufacture in a licensed Manufacturing premises on mutual agreement.

2) A loan license may also be issued to manufacture the Drugs of another Licensed Manufacturer on mutual agreement.

3) Loan licenses are issued separately for the Manufacture of Schedule ‘C’ and ‘C1’ Drugs and Drugs other than Schedule ‘C’, ‘C1’ and ‘X’ (like general Drugs, Schedule ‘G’ and Schedule ‘H’ Drugs).

4) Loan license is not issued for the Manufacture of Schedule ‘X’ Drugs.

5) Licensee should make his own arrangement for the appointment of “Expert Technical Staff” and other workers.

6) He shall follow all the conditions prescribed for the Manufacture of Drugs including GMP.

7) He shall maintain separate Records / Registers, Invoices of purchase of Bulk Drugs, Invoices of sales etc.

8) The stock of raw materials and finished products should be stored separately under lock and key.

9) If the licenses of the original Manufacturer is suspended or cancelled due to any reasons, the license of loan licensee also gets either suspended or cancelled automatically and he cannot continue to Manufacture in that premises or claim any rights over his licenses of Manufacturing.

10) He should also fulfill all the conditions similar to that of a manufacturing license.

Repacking license

Repacking is the process of breaking up Drugs or Chemicals from a Bulk container and transferring them to smaller containers, packing, sealing and labeling which are meant for sale under a “Repacking license” obtained from the licensing authority (Drugs control Dept.)

1) A Repacking license is issued only for Drugs other than Schedule ‘C’, ‘C1’, ‘G’ and ‘H’ Drugs and Chemicals and the License is issued in Form No. 25-B for such applicants who wishes to open / start a Repacking unit.

2) The building/premises meant for repacking should fulfill the requirement mentioned under Schedule ‘M’ of the ‘D’ and ‘C’ act

3) Building should have at least four sections namely:-

a. One section for storing the Bulk Drugs

b. One section for repacking process

c. One section for keeping/storing the finished products and

d. One section for analysis (if possible).

4) Repacking process should be carried out only under the Supervision of a ‘Competent Person’ (A competent person is the one who holds a Diploma in Pharmacy or a Registered Pharmacist or a person who has completed P.U.C or 12thStd with at least two years of experience in Repacking and approved by licensing authority or a person who has completed S.S.L.C. with at least 4 years of Experience in Repacking and Approved by Licensing Authority).

5) Strict Hygienic conditions and GMP should be followed during the Repacking Process

6) All Records of purchase of Bulk Drugs, Stock Register, Sales Register, Sales Invoices etc. should be maintained by the licensee and produced whenever demanded by a Drugs inspector or licensing authority.

7) Drugs Inspector or any other authorized officers of the licensing authority should be allowed to inspect the premises and allow them to take samples of Drugs and chemicals repacked for getting them tested and analyzed for their purity and strength by a Government analyst.

8) Licensee should allow the Drug inspector to enter his observations in the Inspection Book No. 35 to be maintained by him.

9) He should make his own arrangement for getting the samples of bulk Drugs and repacked Drugs tested and analyzed in an approved Analytical Laboratory as per schedule ‘U’ of D and C Act and maintain the records of repacking and analysis for at least 3 years (if he doesn’t have his own Analytical Laboratory).

10) He should purchase the Bulk Drugs only from the Licensed Manufacturers or Distributors for repacking purpose.

11) He should also fulfill any other conditions of repacking license.

-:Thank You:-