DRUGS & COSMETICS ACT 1940 and rules 1945.pptx

This presentation will give knowledge on Drugs and Cosmetic Act 1940 & Rules 1945 which regulates the import, manufacture and distribution of drugs and cosmetics in India.

1. DRUGS & COSMETICS ACT1940 and Rules1945 Syed Arshiya M.Pharmacy Pharmaceutical Regulatory Affairs

2. Introduction: The Drugs and Cosmetics Act, 1940 is an  act of the parliament of India  which regulates the import, manufacture and distribution of drugs in  India. The primary objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards. The related Drugs and Cosmetics Rules, 1945  contains provisions for classification of drugs under given schedules and there are guidelines for the storage, sale, display and prescription of each schedule.

3. Objectives: To ensure the safety, efficacy, and quality of drugs and cosmetics. To regulate the import, manufacture, distribution and sale of drugs and cosmetics through licensing. T o regulate the manufacture and sale of Ayurvedic, S iddha and U nani drugs. To establish DTAB & DCC for allopathic and related drugs and cosmetics. To prevent the manufacturing of spurious and substandard drugs. To prevent the marketing of drugs and cosmetics with misleading claims about their effectiveness and safety. To protect the consumers from potentially harmful products.

4. Definitions: Drug: Any chemical substance used internally or externally in humans and animals for the purpose of diagnosis, treatment, mitigation or prevention of any disease or disorder is considered as Drug. Cosmetics: A ny 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.

5. Spurious Drug: A drug shall be deemed to be spurious if it is manufactured under a name which belongs to another drug, if it is an imitation of another drug or if it has been substituted wholly or partly by another drug or if it wrongly claims to be the product of another manufacturer. Misbranded Drug: A drug shall be deemed to be misbranded if its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular . Adulterated Drug: If it consists, in whole or in part, of any filthy, putrid or decomposed substance; or if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filth or of any poisonous or deleterious substance  whereby it may have been  rendered injurious to health.

6. Patent or Proprietary medicine: A patent medicine (sometimes called a proprietary medicine) is a non-prescription medicine or medicinal preparation that is typically protected and advertised by a trademark  and  tradename, and claimed to be effective against minor disorders and symptoms, as opposed to a  prescription drug  that could be obtained only through a pharmacist, usually with a doctor's prescription, and whose composition was openly disclosed.

7. Schedules to the Act & Rules: There are two schedules in the Drugs and Cosmetics Act, 1940 and its Rules 1945 First schedule: List of Ayurvedic, Siddha and U nani books Second schedule: Various standards to be compiled with by imported drugs and by drugs manufactured for sale, sold, stocked or exhibited for sale or distributed

8. Schedule Content A Application or Performa for issuing licences, granting licenses. Performa for forms no. 1 to 50. B Fees for test or analysis to CDL or Govt.Analyst C List or special & Biological products (parenteral) Ex: Sera, Vaccines, Toxin, Antitoxin etc… C1 List or special & Biological products (Non-parenteral) Ex: Digitalis, Hormones, Ergot D Drugs exempted for export or import E1 List of poisonous substance in Ayurveda, siddha and Unani F Provision applicable to Blood bank requirements

9. Schedule Content F1 Provision applicable to vaccines, Antisera and Diagnostic agents F2 Standards for surgical dressings F3 Standards for umbilical tapes FF Standards for ophthalmic preparations G List of substances should be used under supervision of registered medical Practitioner Ex: Metformin, Anti Histaminic etc… H List of substances should be sold on prescription Ex: Atenolol, Lorazepam, Dapsone etc… J List of disease and ailments that drug may not claim to cure Ex: Cancer, AIDS, Diabetes etc…

10. Schedule Content K List of drugs that are exempted regarding manufacture M Requirements for Good Manufacturing Practice (GMP) M1 Requirements for Homeopathic medicines M2 Requirements for Cosmetics M3 Requirements for Medical devices N List of minimum requirements to run an efficient pharmacy O Standards for disinfectant fluids Ex: Phenol, Alcohol, Hydrogen peroxide (H2O2)

11. Schedule Content P Life period of drugs Ex: Insulin inj – 24 months P1 Pack size of drugs Q List of coal tar colours permitted to be used in cosmetics Ex: Caramel, TiO2 R Standard for condoms made up of rubber latex intended for single use R1 Standard for medical devices S Standard for cosmetics T Requirements GMP of factory premises for Ayurvedic, Siddha, Unani drugs

12. Schedule Content U Manufacturing and Analytical records of drugs U1 Manufacturing and Analytical records of cosmetics V Standards for patent or proprietary medicines W List of drugs marketed under generic names X List of narcotic drugs and psychotropic substances Ex: Opium, Morphine, Barbital etc… Y Requirements and guidelines on clinical trials for import and manufacture of new drugs

13. Import of drugs: Any substance falling within the definition of drug required to be registered before import into the country. Not only drug but also the manufacturing site needs to be registered for import of drugs.

14. Classes of drugs prohibited from import: Misbranded drugs Spurious drugs Adulterated drugs Drugs claiming to cure diseases specified in schedule-J 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 disclose

15. Import of the Biological drugs (C/C1) Conditions to be fulfilled: Licensee must have adequate facility for the storage. Licensee must maintain a record of the sale. Licensee must allow an inspector to inspect promises and to cheque the records. Licensee must furnish the sample of the authority.

16. 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 licence granted even before should not be suspended or cancelled. The licensee has not been convicted any offence under the Drugs and Cosmetic A ct or Narcotic and Psychotropic substances Act.

17. Drugs imported for personal use Conditions to be fulfilled: Up 100 average chooses may be imported without any permit, provided it is part of passengers luggage. More than 100 doses imported with license apply on form no: 12-A, 12-B. Drugs must be bonafide personal use. The quantity should be covered by RMP prescription. Drugs must be declared to the custom collector if so directed.

18. Import of drugs without licence Substances not used for medicinal purpose. Drugs in schedule C1 required for manufacturing and not for medicinal use Substances which are both drugs and foods such as Condensed/powdered milk Malt L actose Farex / cereal Oats Pre-digested food Karma Ginger Karma Paper Karma cumin, cinnamon .

19. Penalties related to import Offences Penalties Imported of spurious or adulterated drugs or drug which involves risk to human beings or animals or drug not having therapeutic values. 3 years imprisonment or 5000 rs . Fine in first conviction 5 years imprisonment or 1000 rs . Fine or both for subsequent conviction. Contravention of the provision. 6 months imprisonment or 500 rs . Fine or both for first conviction. 1 year imprisonment or 1000 rs . Fine for subsequent offence.

20. Cosmetics prohibited to import Misbranded cosmetics Spurious cosmetics Cosmetics containing harmful ingredients Cosmetics not of standard quality Cosmetics which contain more than 2 ppm Arsenic, 20 ppm Lead, 100 ppm heavy metals

21. Manufacture of drugs Pharmaceutical manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs as part of the pharmaceutical industry. The process of drug manufacturing can be broken down into a series of unit operations, such as milling, granulation, coating, tablet pressing, and others.

22. Prohibition of manufacture of certain drugs Misbranded drugs Spurious drugs Adulterated drugs Drugs claiming to cure diseases specified in schedule-J Patent/proprietary medicines Drugs without therapeutic value

23. Manufacture of drugs belonging to schedule - C/C1 Manufacture of drugs other than schedule - C/C1 Manufacture of drugs belonging to schedule - X Loan license Repacking license Offences & penalties

24. Manufacture of drugs belonging to schedule - C/C1 Conditions to be fulfilled: Drugs must be issued in previously sterilized sealed glass or suitable container Containers should comply with schedule-F Some classes tested for aerobic & anaerobic micro organism Ex: sera, insulin, pituitary hormones Serum tested for abnormal toxicity Parenteral in doses of 10ml or more should be tested for freedom from pyrogens Separate lab for culture & manipulation of spore bearing pathogens Test of sterility should be carried out

25. Manufacture of drugs other than schedule -C/C1 Conditions to be fulfilled : Premises should comply with schedule-M Adequate facility for testing, separate from manufacturing Adequate storage facility Records maintained for at least 2 years from date of expiry Provide sample to authority Furnish data of stability Maintain the inspection book Maintain reference samples from each batch

26. M anufacture of drugs belonging to schedule -X Conditions to be fulfilled : Accounts of all transactions regarding manufacture should be maintained in serial order. Have to sent invoice of sale to licensing authority every 3 months Store drugs in direct custody of responsible person. Preparation must be labelled with XRx Marketed in packings not exceeding 100 unit dose - Tablets/Capsules 300 ml – Oral liquid 5 ml - Injection

27. Loan license Definition A loan license is one that a licensing authority may provide to a candidate who lacks his own manufacturing arrangements but plans to use the production facilities controlled by another licensee. It is issued for the production, sale, or distribution of medications not included in Schedules C, C1, or X.

28. Repacking License Definition: The process which involves breaking up any drug from a bulk container and packing into small packages and labelling with a view to their sale and distribution is called repackaging license.

29. Penalties related to Manufacture Offences Penalties Manufacture of any spurious drugs 1-3 years imprisonment and rs.5000 fine. 2-6 years imprisonment and rs.10,000 fine on subsequent conviction. Manufacture of any adulterated drugs 1 year imprisonment and rs.2000 fine. 2 years imprisonment and rs.2000 fine on subsequent conviction. Manufacture of drugs in contravention of the provisions Imprisonment up to 3 months and rs.500 fine. Imprisonment up to 6 months and rs.1000 fine on subsequent conviction.

30. Cosmetics prohibited to Manufacture Misbranded cosmetics Spurious cosmetics Cosmetics containing harmful ingredients Cosmetics not of standard quality Cosmetics which contain more than 2 ppm Arsenic, 20 ppm Lead, 100 ppm heavy metals Eye preparations containing coal tar color

31. Sale of drugs In India, the Drugs and Cosmetics Act, 1940 regulates the sale of drugs, including Ayurvedic , Siddha, and Unani products. The act also covers the manufacture, import, and distribution of drugs and cosmetics .

32. Prohibition of Sale of certain drugs Misbranded drugs Spurious drugs Adulterated drugs Drugs claiming to cure diseases specified in schedule-J Patent/proprietary medicines Drugs without therapeutic value

33. Wholesale of biological (C/C1) Adequate premises, with greater than 10 meter square 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 and sale Records preserved for 3 years from date of sale License should displayed on premises

34. Wholesale of drugs other than schedule - C/C1 & X All the conditions as discussed in for biological. Compounding is made by or under the direct and personal supervision of a qualified person.

35. Labelling & Packaging: All the general and specific labelling and packaging specified to all classes of drugs and cosmetics should be as per the provisions made under the act.

36. Reference: https://en.wikipedia.org/wiki/Drugs_and_Cosmetics_Act,_ 1940 https://cdsco.gov.in/opencms/opencms/en/Acts-and-rules/Drugs-and-Cosmetics-Act / https:// cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf

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