Drugs and Cosmetics Act 1940 and Rules 1945

Drugs and Cosmetics Act 1940 and Rules 1945 SJTPC 1

Contents History and Objectives Definitions Administration of the act and rules Provisions related to Import Provisions related to Manufacture Provisions related to Sale Labeling and Packaging Schedules to the act and rules Recent amendment act, 2008 List of forms SJTPC 2

History British misrule-Providing poor healthcare system to Indian citizens Observations made by-Drugs Enquiry Committee, Indian Medical Association Reports in- Indian Medical Gazette during 1920 -30 1940 – Drugs and Cosmetics Act 10 th April 1940 1945 – Rules under the Act Extended to whole of India…… SJTPC 3

LIST OF AMENDING ACTS AND ADAPTATION ORDERS 1. The Drugs (Amendment) Act, 1955 2. The Drugs (Amendment) Act, 1960 3. The Drugs (Amendment) Act, 1962 4. The Drugs and Cosmetics (Amendment) Act, 1964 5. The Drugs and Cosmetics (Amendment) Act, 1972 6. The Drugs and Cosmetics (Amendment) Act, 1982 7. The Drugs and Cosmetics (Amendment) Act, 1995 8. The Drugs and cosmetics (Amendment) Act, 2008 SJTPC 4

Objectives • To regulate the import, manufacture, distribution and sale of drugs & cosmetics through licensing. • Manufacture, distribution and sale of drugs and cosmetics by qualified persons only. • To prevent substandard in drugs. • To regulate the manufacture and sale of Ayurvedic, Siddha and Unani drugs. • To establish Drugs Technical Advisory Board(DTAB) and Drugs Consultative Committees(DCC) for Allopathic and allied drugs and cosmetics. SJTPC 5

Definitions • Drugs : All medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes. SJTPC 6

• Cosmetic : Any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic. SJTPC 7

Misbranded drugs : (a) if it is so colored, coated, powdered or polished that damage is concealed or if it is made to appear of better or greater therapeutic value than it really is; or (b) if it is not labelled in the prescribed manner. 8

• Adulterated drug : (a) if it consists, in whole or in part, of any filthy, putrid or decomposed substance; or (b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health; or (c) if its container is composed in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health. 9

• Spurious drugs : (a) if it is imported under a name which belongs to another drug; or (b) if it is an imitation of, or a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug Spurious -Not Genuine 10

• Manufacture : In relation to any drug or cosmetic, it includes any process or part of a process for making, altering, ornamenting, finishing, packing, labelling, breaking up or otherwise treating or adopting any drug or cosmetic with a view to its sale or distribution but does not include the compounding or dispensing of any drug, or the packing of any drug or cosmetic, in the ordinary course of retail business.

• Patent or Proprietary medicine : A drug which is a remedy or prescription presented in a form ready for internal or external administration of human beings or animals and which is not included in the edition of the Indian Pharmacopoeia for the time being or any other Pharmacopoeia authorized in this behalf by the Central Government.

Administration of the act and rules A) Advisory : 1)Drugs Technical Advisory Board-DTAB 2)Drugs Consultative Committee-D. C. C. B) Analytical : 1)Central Drugs Laboratory - CDL 2)Drug Control Laboratory in states 3)Government Analysts C) Executives : 1)Licensing authorities 2)Controlling authorities 3)Drug Inspectors

Drugs Technical Advisory Board(DTAB) • Ex-Officio: (i) Director General of Health Services (Chairman) (ii) Drugs Controller, India (iii)Director of the Central Drugs Laboratory, Calcutta (iv) Director of the Central Research Institute, Kasauli (v)Director of Indian Veterinary Research Institute, Izatnagar (vi) President of Medical Council of India (vii) President of the Pharmacy Council of India (viii)Director of Central Drug Research Institute, Lucknow

Nominated: 1) Two persons by the Central Government. 2) One person by the Central Government from the pharmaceutical industry 3) Two persons holding the appointment of Government Analyst under this Act,

Elected: 1)one person, to be elected by the Executive Committee of the Pharmacy Council of India, 2)one person, to be elected by the Executive Committee of the Medical Council of India, 3)one pharmacologist to be elected by the Governing Body of the Indian Council of Medical Research; 4)one person to be elected by the Central Council of the Indian Medical Association; 5)one person to be elected by the Council of the Indian Pharmaceutical Association;

• Functions: 1. To advise the Central Government and the State Governments on technical matters. 2. To carry out the other functions assigned to it by this Act.

Drugs Consultative Committee(DCC) • It is also an advisory body constituted by central government. • Constitution: 1. Two representatives of the Central Government 2. One representative of each State Government

Functions: 1. To advise the Central Government, the State Governments and the Drugs Technical Advisory Board on any other matter tending to secure uniformity throughout India in the administration of this Act. 2. The Drugs Consultative Committee shall meet when required 3. Has power to regulate its own procedure. 19

CENTRAL DRUG LABORATORY(CDL) Established in Calcutta, under the control of a director appointed by the Central Government. Functions: Analysis or test of samples of drugs/cosmetics sent by the custom collectors or courts. Analytical Q. C. of the imported samples. Collection, storage and distribution of internal standards. Preparation of reference standards and their maintenance. Maintenance of microbial cultures. Any other duties entrusted by Central Government. Acting as an appellate authority in matter of disputes. 20

In DRUG CONTROL LABORATORIES IN STATE Gujarat three laboratories established which collect, analyzed and report the various sample of the drugs and food. 1) Baroda: Established in 1959. 2) Bhuj: Established in 1979. 3) Rajkot: Established in 1983. The laboratory has the following division: Pharmaceutical Chemistry Division Immunology Division Pharmacognosy Division Food Division Ayurvedic Division 21

Function: • Testing of drug sample • Analysis of food sample • Analysis of excise sample

Government analyst • These officers are appointed by the central or state government and perform the duties. Qualification of Government analysist 1. Persons having qualification for appointment as government Analysist for allopathic drugs ; 2. having a degree in medicine, Ayurveda, siddha or unani system and not less than three year post graduate experience in the analysis of drugs in a laboratory under control of a government analyst.

Duties: • 1) The Government Analyst shall cause to be analyzed or tested such samples or drugs and cosmetics as may be sent to him by Inspectors. • 2)A Government Analyst shall from time to time forward reports to the Government giving the result of analytical work and research with a view to their publication.

Licensing authority Qualification: (i)Graduate in Pharmacy on Pharmaceutical Chemistry or in Medicine with specialization in clinical pharmacology or microbiology from a University established in India by law; and (ii)Experience in the manufacture or testing of drugs a minimum period of five years, Provided that the requirements as to the academic qualification shall not apply to those inspectors.

Duties: (1) to inspect all establishments licensed for the sale of drugs within the area assigned to him; (2) to satisfy himself that the conditions of the licenses are being observed; (3) to procure and send for test or analysis, if necessary, imported packages. (4) to investigate any complaint.

(5) to maintain a record of all inspections made and action taken by him in the performance of his duties, (6) to make such enquiries and inspections as may be necessary to detect the sale of drugs in contravention to the Act;

Controlling authority Qualification: • graduate in Pharmacy or Pharmaceutical Chemistry or in Medicine with specialization in clinical Pharmacology or microbiology from a University established in India by law and • experience in the manufacture or testing of drugs or enforcement of the provisions of the Act for a minimum period of five years:

Drug Inspector Qualification 1. Persons having qualification for appointment as government Analysis for allopathic drugs ; or 2. having a degree in ayurveda, sidha or unani system and not less than three year post graduate experience in the analysis of drugs in a laboratory under control of (a) a government analyst, or (b) a chemical examiner, or (c) head of an institution specially approved for this purpose.

Power: a) Inspect, -(i) any premises where in any drug or cosmetic is being manufactured. (ii) any premises where in any drug or cosmetic is being sold, or stocked or exhibited or offered for sale, or distributed ; (b) Take samples of any drug or cosmetic--(i) which is being manufactured or being sold or is stocked or exhibited or offered for sale, or is being distributed; (ii) from any person who is in the course of conveying, delivering or preparing to deliver such drug or cosmetic to a purchaser.

Provision of Act Import Manufacturing Sales Labeling & Packaging

IMPORT

IMPORT of drugs • Classes of drugs prohibited to import • Import of drug under license 1)Specified in Schedule-C/C 1 2)Specified in Schedule-X 3)Imported for Test/Analysis 4)Imported for personal use 5)Any new drugs • Drugs exempted from provisions of import • Offences and Penalties

Classes of drugs prohibited to import • • • Misbranded drugs Drugs of substandard quality Drugs claiming to cure diseases specified in Sch-J Adulterated drugs Spurious drugs Drugs whose manufacture, sale/distribution are prohibited in original country, except for the purpose of test, examination and analysis. • Patent/Proprietary medicines whose true formula is not disclosed.

Classes of drugs prohibited to import • Drugs not labelled/packed in prescribed manner. • Drugs of biological products (C/C 1) after the date of expiry • Drugs not claiming therapeutic values. • Drugs which is risky to human beings or animals. • Any new drug except with express permission of LIC. authority.

Import of the biological drugs(C/C 1) Conditions to be fulfillled: • Licensee must have adequate facility for the storage. • Licensee must maintain a record of the sale, showing the particulars of the names of drugs and of the persons to whom they have been sold. • Licensee must allow an inspector to inspect premises and to check the records. • Licensee must furnish the sample to the authority. • Licensee must not sell drugs from which sample is withdrawn and he is advised not to sale, and recall the batch from the market.

Import of the Schedule-X drugs (Narcotic & Psychotropic drugs) Conditions to be fulfilled: • Licensee must have adequate storage facility. • Applicant must be reputable in the occupation, trade or business. • The license granted ever before should not be suspended or cancelled. • The licensee has not been convicted any offence under the Drugs and Cosmetics Act or Narcotic and Psychotropic Substances Act.

Drugs Imported for examination, test or analysis Conditions to be fulfilled: • License is necessary under form-11 • Must use imported drugs only for said purpose and at the place specified in the license. • Must keep the record with respect to quantities, name of the manufacturer and date of import. • Must allow an inspector to inspect the premises and check the records.

Import of drugs without license • Substances not used for medicinal purpose • Drugs in Sch-C 1 required for manufacturing and not for medicinal use. • Substances which are both drugs and foods such as: Condensed/Powdered Milk Lactose Farex/Cereal Oats • Predigested foods • Ginger, Pepper, Cumin, Cinnamon

Penalties related to Import OFFENCES PENALTIES Import of spurious OR adulterated a) 3 years imprisonment and 5000 drug OR drug which involves risk to Rs. fine on first conviction human beings or animals OR drug b) 5 years imprisonment OR 10000 not having therapeutic values Rs. fine OR both for subsequent conviction Contravention of the provision a) 6 months imprisonment OR 500 Rs. fine OR both for first conviction b) 1 year imprisonment OR 1000 Rs. fine for subsequent offence

Import of cosmetics Cosmetics prohibited to import: • Misbranded cosmetics • Spurious cosmetics • Cosmetic containing harmful ingredients • Cosmetics not of standard quality • which contains more than-2 ppm Arsenic, 20 ppm lead, 100 ppm heavy metals

Cont…. • Cosmetics meant for eye and containing coal tar dyes • Cosmetics coloured with lead OR arsenic compounds • Cosmetics containing Hexachlorophene OR Mercury • Risky to user

MANUFACTURE SJTPC 43

Manufacture • • Prohibition of manufacture Manufacture of other than in Sch-C/C 1 Manufacture of those in Sch-C/C 1 Manufacture of Sch-X drugs Loan license Repackaging license Offences & Penalties SJTPC 44

Prohibition of manufacture • Drug not of standard quality or misbranded, adulterated or spurious. • Patent or Proprietary medicine • Drugs which claims to cure diseases specified in Sch-J • Drugs which Risky to human beings or animals • Drugs without therapeutic value • Preparation containing cyclamates

Manuf. of drugs other than in Sch-C/C 1 Conditions: • • • Premises should comply with schedule ‘M’ Adequate facility for testing, separate from manufacturing Adequate storage facility Records of mfg. & testing-maintained for at least 2 years from date of Exp. License should provide sample to authority Furnish data of stability Maintain the inspection book Maintain reference samples from each batch Accounts of production recorded & maintained for 5 years or 1 year after Expiry.

Manuf. of drugs those in Schedule. C/C 1(Biological) Conditions: • Drugs must be issued in previously sterilized sealed glass or suitable container • Containers should comply with req. of Sch-F/F 1 • Drug must comply with std. (quality, purity, strength) specified in sch. -F • Serum tested for freedom from abnormal toxicity • Parenteral in doses of 10 ml or more should be tested for freedom from Pyrogens • Separate lab. for culture & manipulation of spore bearing Pathogens • Test for sterility should be carried out.

Manufacture Of Sch-X drugs Conditions: • Accounts of all transactions regarding manuf. should be maintained in serially bound & paged register. (Preserved for 5 years) • Have to sent invoice of sale to licensing authority every 3 months • Store drugs in direct custody of responsible person. • Preparation must be labeled with XRx • Marketed in packing's not exceeding – 100 unit dose –Tablets/Capsules – 300 ml- Oral liquid – 5 ml - Injection

Loan License • Definition: A person(applicant) who does not have his own arrangements(factory) for manufacture but who wish to manufacturing facilities owned by another licensee. Such licenses are called Loan licenses are issued for: 1) Drugs other than specified in C/C 1 & X. 2) Drugs specified in Schedule-C/C 1

Repackaging license • Definition: Process of breaking up any drug from a bulk container into small packages and labeling with a view to their sale and distribution. Repackaging of drugs is granted of drugs other than Schedule-C/C 1 and X.

Penalties related to Manufacture OFFENCES PENALTIES Manufacture of any spurious drugs a) 1 -3 years imprisonment and Rs. 5000 fine b) 2 -6 years imprisonment & Rs. 10000 fine on subsequent conviction Manufacture of adulterated drugs a) 1 year imprisonment & Rs. 2000 fine b) 2 years imprisonment & Rs. 2000 fine for subsequent conviction Manuf. of drugs in contravention of a) Imprisonment up to 3 months & the provisions Rs. 500 fine b) Imprisonment up to 6 months & Rs. 1000 fine on subsequent conviction SJTPC 52

Manufacture of cosmetics Prohibited for the following classes of drug: • Misbranded or spurious cosmetics and of substandard quality • Cosmetics containing hexachlorophene or mercury compounds • Cosmetics containing color which contain more than- 2 ppm of arsenic - 20 ppm of lead - 100 ppm of heavy metals • Eye preparations containing coal-tar color

SALE

Sale of Drugs • Classes of drugs prohibited to be sold • Wholesale of biological (C/C 1) • Wholesale of other than those specified in C/C 1 and X

Class of drug prohibited to sale • Misbranded, spurious, adulterated and drugs not of standard quality • Patent/Proprietary drugs with undisclosed formula • Sch-J drugs • Expired drugs. • Drugs used for consumption by government schemes such as, Armed force. • Physician’s samples

Wholesale of biological (C/C 1) • Adequate premises, with greater than 10 M 2 area, with proper storage facility • Drugs sold only to retailer having license • Premises should be in charge of competent person who is Reg. Pharmacist. • Records of purchase & sale • Records preserved for 3 years from date of sale • License should displayed on premises

whole sale from other than specified in c/c 1 and x • All the conditions as discussed in for biological. • Compounding is made by or under the direct and personal supervision of a qualified person.

Labeling & Packaging • All the general and specific labeling and packaging specified to all classes of drugs and cosmetics should be as per the provisions made under the act. 59

Schedules to the rules TYPE CONTENT “A” Performa forms no. 1 to 50( Application, issue, renewal, etc. ) “B” Rates of fee for test or analysis by CDL or Govt. analysts “C” List of Biological and special products (Injectable) applicable to special provisions. Ex. Sera, Vaccines, Penicillin…. . etc “C 1” List of Biological and special products (nonparenteral) applicable to special provisions. Ex. Digitalis, Hormones , Ergot “D” List of drugs that are exempted from provisions of import “E 1” List of poisonous substances under the Ayurvedic , Siddha and Unani systems “F” Provisions applicable to blood bank

Schedules to the rules TYPE CONTENT “F 1” Special provision applicable to biological and special products, eg. Bacterial and viral vaccines, sera from living animals, bacterial origin diagnostic agents “F 2” Standards for surgical dressings “F 3” Standards for umbilical tapes “FF” Standards for ophthalmic preparations “G” List of substances required to be used under medical supervision and labelled accordingly Ex. Metformin, Anti Histaminic, …etc “H” List of substances (prescription) that should be sold by retail only on prescriptions of R. M. P. Ex. Atenolol, Lorazepam, Dapson …etc

Schedules to the rules TYPE CONTENT “J” List of diseases and ailments that drug should not claim to cure Ex. Cancer, AIDS, Cataract, Diabetes…etc “K” List of drugs that are exempted from certain provisions regarding manufacture “M” Requirements of manufacturing premises, GMP requirements of factory premises, plants and equipments “M 1” Requirements of factory premises for manufacture of Homeopathic medicines “M 2” Requirements of factory premises for manufacture of cosmetics “M 3” Requirements of factory premises for manufacture of medical devices “N” List of equipment to run a Pharmacy “O” Standards for disinfectant fluids Ex… Phenol, H 2 O 2, alcohol….

Schedules to the rules TYPE CONTENT “P” Life period(expiry) of drugs Ex. Insuline Inj. – 24 months “Q” Coal tar colors permitted to be used in cosmetics Ex. Caramel, Ti. O 2. “R” Standards for mechanical contraceptives “R 1” Standards for medical devices “S” Standards for cosmetics “T” Requirements (GMP) of factory premises for Ayurvedic, Siddha, Unani drugs Manufacturing and analytical records of drugs “U”

Schedules to the rules TYPE CONTENT “U 1” Manufacturing and analytical records of cosmetics “V” Standards for patent or proprietary medicines “W” List of drugs marketed under generic names- Omitted “X” List of narcotic drugs and psychotropic substances EX. Opium, Morphine, Barbital…… “Y” Requirement and guidelines on clinical trials for import and manufacture of new drugs

References • www. cdsco. nic. in • “Pharmaceutical Jurisprudence”, Jani GK, Atul prakashan; Fifth edition(2005 -06); 28. • “Forensic Pharmacy”, Kokate CK and Gokhle SB, Pharma Book Syndicate; 152 • “Laboratories” http: //www. gujhealth. gov. in/fdclaboratory. htm