drug and cosmetic act

APOPTOSIS(General Introduction)

Drug and Cosmetics act and new Amendment of ASU Drugs

Co-Guide:Dr. Sananth Kumar D.G(MD Ayu)Professor Department of PanchakarmaKVG Ayurvedic college and Hospital,Sullia

By:Dr.Saurav Verma 2nd Year PG scholarDepartment of PanchakarmaKVG Ayurvedic College and Hospital, SulliaGuide:Dr. Pradeep J.M(MD Ayu)Reader Department of PanchakarmaKVG Ayurvedic college and Hospital,Sullia

ContentsObjective DefinitionsAdministration of act and rulesProvision related to Import Provision related to ManufactureProvision related to saleLabelling and packing Recent amendment act,2015List of forms

Objectives

To regulate the import, manufacture, distribution and sale of drugs and cosmetics through licensing.Manufacture , distribution and sale of drugs and cosmetics by qualified persons only.To control the manufacture, import and sale of ASU drugs.To establish Drugs Consultative Committees(DCC).To secure the maintenance of uniformity in standard of ASU drugs

DefinitionsDrugs:Ayuvedic, Siddha or Unani Drugs includes all medicines intended for internal or external use for or in thediagnosis, treatment, mitigation or prevention of [disease or disorder in human beings or animals, manufactured exclusively in accordance with the formulae prescribed in the authoritative books of [Ayurvedic, Siddha and Unani Tibb systems of medicine, specified in the First Schedule.Cosmetics:Any article intended to be rubbed , poured , sprinkled or sprayed on, or introduced into, or applicated to, the human body or any part there of for cleaning, beautifying, promoting attractiveness, or altering the appearance.

Manufacture:-Any process or part of a process for making , altering, finishing, packing, labelling, breaking up or treating or adopting any drugs/cosmetic with a vies of its sale and distribution.It does not include the compounding or dispensing of any drug or the packing of any drug or cosmetic.

Patent or Proprietary Medicine

in relation to Ayurvedic, Siddha or Unani Tibb systems of medicine all formulations containing only such ingredients mentioned in the formulae described in the authoritative books of Ayurveda, Siddha or Unani Tibb systems of medicine specified in the First Schedule,

But does not include a medicine which is administered by parenteral route and also a formulation included in the authoritative books as specified in clause

Spurious Drugs:- If it is sold, or offered or exhibited for sale, under a name which belongs to another drug. If it is an imitation of, or is an 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, unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug.

Misbranded Drugs:-If it is so coloured , coated, powdered or polished that damage is concealed or if it is made to appear of better or greater therapeutic valve.If it is not labelled in the prescribed manner.f 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 Drugs:-If it consists, in whole or in part, of any filthy, putrid or decomposed substance. 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.

Administration of the act and rules Advisory:Drugs Technical advisory Board-DTABDrugs Consultative committee-DCCAnalytical:Central Drugs laboratory-CDLDrug Control Laboratory Government AnalystsExecutives:Drug Inspector Licensing AuthoritiesControlling authorities

Drug Technical Advisory BoardConsists of Following Members (ex officio)Drugs controller, India Director General of Health ServicesThe principal officer dealing with Indian systems of medicine in the Ministry of HealthOne person holding the appointment of Government Analyst under Section 33-F to be nominated by the Central GovernmentDirector of the Central Drugs Laboratory, Calcutta One Pharmacognocist to be nominated by the Central Government One Phyto-chemist to be nominated by the Central Government4 persons to be nominated by the Central Government, two from amongst the members of the Ayurvedic Pharmacopoeia Committee, one from amongst the members of the Siddha and Unani Pharmacopoeia Committee.

Nominated:

3 persons, one each to represent the Ayurvedic, Siddha and Unani drug industry, to be nominated by the Central Government.3 persons, one each from among the practitioners of Ayurvedic, Siddha and Unani Tibb systems of medicine to be nominated by the Central Government.One teacher in Darvyaguna, and Bhaishajya kalpana, to be nominated by the Central Government.One teacher in Gunapadam to be nominated by the Central Government.

Drugs Consultative Committee(DCC)It is also an Advisory Body consist of two representative central government to be nominated by Government .One representative of each state Government to be nominated by the State Government.Function:It shall meet when required.It has power to regulate its own procedure.

Central Drug Laboratory(CDL)Established in Calcutta under the control of Director appointed by central government.

Functions:Collection , storage, and distribution of internal standards.Maintenance of microbial cultures.Analytical Q.C of the imported samples.Analysis or test of samples of drugs/cosmetics.Any other duties given by central Government.

The Laboratory has the Following Division:-

Chemistry DivisionMicrobiology SectionPharmacology DivisionFood DivisionPharmacognocy DivisionAyurvedic Division

CHEMISTRY SECTION Alcohol determination apparatus complete set. Volatile oil determination apparatus. Boiling point determination apparatus. Melting point determination apparatus. Refractometer. Polarimeter. Viscometer (Ostwalds, Redwood viscometer). Tablet disintegration apparatus.Moisture determination apparatus. (IC filtrator).U.V. Spectro-Photometer.Muffle furnace. Dehumidifier (where necessary).PH meter.

Electronic Balance. Hot air oven (s) different range of temperature/vacuum oven. 14. Refrigerator. Glass distillation apparatus/plant.Water supply demineralised exchange equipment/distillation equipment.Air conditioner.LPG Gas Cylinder with burners. 19. Water bath (temperature controlled)Heating mantle (4) or as required. TLC apparatus with all accessories.Sieves 10 to 120 with sieve shaker.Centrifuge macG.L.C. with F.I. detector. Silica crucible.hine

PHARMACOGNOSY SECTIONMICROBIOLOGY SECTIONMicroscope binocular.Dissecting Microscope.MicrotomeChemical balance. Microslide cabinet.Aluminium slide trays.Hot air oven.Occular Micrometer.Stage Micrometer.Camera Lucida Prism type and mirror type. Hot plates. Refrigerator. LPG Cylinder with burners.Other related equipments, reagents, glasswares, etc. Laminar air flow bench (L.A.F.)B.O.D. Incubator. Plain incubator.Serological water bath.Oven. Autoclave/Sterilizer.Microscope (high power).Colony counter. Other related equipment and reagents

Government Analyst:-

These officers are appointed by the Central or State Government and perform the duties.Persons having Qualification for appointments as government as governmental analysis for drugs;Must have a degree in Medicine/Ayurveda/Sidha/Unani system and not less than 3 year post graduate experience in the analysis of drug.

Duties:Analysed or tested such sample or drugs and cosmetics may be sent to him by Inspectors.Timely forward reports to the Government giving the results of analytics work.

Licensing Authority:-

Qualification:All member should be Graduate in Pharmacy on Pharmaceutical Chemistry or in Medicine with Specialization in Clinical pharmacology or microbiology.5 year Experience in manufacture or testing of a drugs.

Duties:To inspect all establishments licensed for the sale of drugs within the area assigned to him.To send for test or analysis.To investigate any complaint.To maintain a record of all inspections made by him.To maintain a record of action taking by him in the performance of his duties.

Drug Inspector:

Qualification: Has degree in Ayurvedic or Siddha or Unani system or a degree in Ayurveda Pharmacy, as the case may be, conferred by a University or a State Government or a Statutory Faculty, Council or Board of Indian Systems of Medicine recognized by the Central Government or the State Government.Has a diploma in Ayurveda, Siddha or Unani System, as the case may be, granted by a State Government or an Institution recognized by the Central Government or a State Government for this purpose).Who have not less than 18 months experience in testing of at least one of the substances in Schedule C in a laboratory approved for this purpose by the licensing authority.Who have gained experience of not less than three years in the inspection of firm manufacturing any of the substances specified in Schedule C

.

Function:Inspection of all area where the drug and cosmetics are being manufactured/sold/stocked.Take sample of any drug and cosmetic are being manufactured/sold/stocked

Provision Of Import:Import of drug under licenseImported for Test/AnalysisSpecified in Schedule-C/C1Specified in Schedule-XImported for personal use any new drugsOffences and PenaltiesDrugs exempted from provisions of import.Classes of drugs prohibited to import.Misbranded drugsDrugs of substandard qualityAdulterated drugsSpurious drugsDrugs whose manufacture, sale/distribution are prohibited in original country; expect for the purpose for test/examination/analysis.Patent medicines whose true formula is not disclosed.

Import of Drugs Without License:Drugs in Sch-C1 required for manufacturing and not for medicinal use.Substance not used for medicinal purpose.Pre-digested foods.Ginger, pepper, cumin, cinnamon.

Substance which are both drugs and foods such as:Powdered milkOatsCereal/farexMaltlactose

Cosmetics Prohibited to Import:Misbranded cosmeticsSpurious cosmetics Cosmetic containing harmful ingredientsCosmetics not of standard qualityWhich contains more than 2ppm Arsenic,20ppm lead, 100 ppm heavy metals.

Manufacture:Prohibition of manufacture.Manufacture of other than in Sch-C/C1.Manufacture of those in Sch-C/C1Manufacture of Sch- X drugsLoan licenseRepacking licenseOffences and penalties.Prohibition of Manufacture:Drug not of standard quality or misbranded, adulterated or spurious.Patent medicine.Drugs in Sch-JRisky to animal/human.

Sch-X drugs(condition)Store drugs in direct under of responsible person.Invoice of sale must sent to licensing authority every 3 months.Preparation must be labelled with XRx.Marketed in packing not exceeding: 100 unit dose300ml of oral liquid5ml- injection Manuf. Of drugs other than in Sch-C/C1Adequate facility for testing, separating from manufacturing.Premises should comply with schedule M.Adequate storage facility.Furnish data of stability.Maintain the inspection book.Maintain reference samples from each batch.

Loan License:a person who does not have his own arrangements(factory) from manufacture but who wish to manufacturing facilities owned by another license. Such license are call loan license.

Repackaging License:Process of breaking up any drug from a bulk container into small packages and labelling with a view to their sale and distribution.Repackaging of drugs is granted of drugs other than Schedule-C/C1 and X.

OFFENCESPENALTIESManufacture of any spurious drugs

Manufacture of adulterated drugs

Any Ayurvedic, Siddha or Unani drug deemed to be spurious under Section 33EEA, shall be punishable with imprisonment for a term which shall not be less than one year but which may extend to three years and with fine which shall not be less than five thousand rupees.

1 year imprisonment and 2000 fine2 year imprisonment and 200 fine on subsequent conviction

Manufacture of CosmeticsMisbranded or spurious cosmetics and of substandard quality.Cosmetics contain Hexachlorophene or mercury compoundsContaining:2ppm or arsenic20ppm of lead100ppm of heavy metalsEye preparations containing coal-tar colour.

Sale of drugs:

Classes of drugs prohibited to be soldMisbranded , spurious, adulterated and drugs not of standard qualityPatent medicineSch-J drugsExpired drugsPhysician sampleWholesale of other than those specified in C/C1 and X.All the conditions as discussed in for biologicalCompounding is made by or under the direct and personal supervision of qualified person.

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.For ASU DrugsThe true list of all the ingredients used in the manufacture of the preparation together with the quantity of each of the ingredients incorporated therein and a reference to the method of preparation thereof as detailed in the standard text and adikarana, as are prescribed in the authoritative books .The container of a medicine for internal use made up ready for the treatment of human ailments shall, if it is made up from a substance specified in Schedule E(1), be labelled conspicuously with the words Caution: to be taken under medical supervision both English and Hindi languages.The name of the drug. For this purpose the name shall be the same as mentioned in the authoritative booksThe name and address of the manufacturer.The number of the licence under which the drug is manufactured, the figure representing the manufacturing licence number being preceded by the words Manufacturing Licence Number of Mfg Lic. No or M.L

The words FOR EXTERNAL USE ONLY if the medicine is for external application.A distinctive batch number, that is to say, the number by reference to which details of manufacture of the particular batch from which the substance in the container is taken are recorded and are available for inspection, the figure representing the batch number being preceded by the words batch No. or Batch or Lot Number or Lot No. or Lot or any distinguishing prefix. vi) The date of manufacture. For this purpose the date of manufacture shall be the date of completion of the final products, or the date of bottling or packing for issue.

Standards of Ayurvedic, Siddha and Unani Drugs[***] drugs included in Ayurvedic Pharmacopoeia

Asavas abd AristasThe standards for identity, Purity and strength as given in the editions of Ayurvedic Pharmacopoeia of India for the time being in force.

The upper limit of alcohol as self generated alcohol should not exceed 12% v/v excepting those that are otherwise notified by the Central Government from time to time.

Schedules1st schedule:- Name of Book under Ayurveda and Siddha system.2nd schedule:- Standard to be compiled with by imported drugs and by drugs manufactured for sale , sold, stocked for sale/distribution

Drug and cosmetics (Amendment) Act, 2015(Draft)Salient Features of the Act:This act may be called the D&C (amendment) Act, 2014.It shall come into force on such as the central Government may, by notification in the Official Gazette, appoint.Provided that different dates may be appointed for different provisions of this act and may reference in any such provision to the commencement of this Act shall be construed as a reference to the coming into force of that provision.Ayurvedic, Siddha or Unani drug includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, and manufactured exclusively in accordance with the formulae described in, the authoritative books of Ayurvedic, Siddha and Unani Tibb systems of medicine, specified in the First Schedule;

For the word Inspector wherever it occurs, the words Drugs Control Officer shall be substituted.In section 1 of the principal Act, in sub-section (1), for the words and Cosmetics, the words , Cosmetics and Medical Devices shall be substituted. in relation to Ayurvedic, Siddha or Unani drug, the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board constituted under section 33C; in relation to Ayurvedic, Siddha or Unani drug, a Drugs Control Officer appointed by the Central Government or a State Government under section 33G; in relation to Ayurvedic, Siddha, Unani drug, a Government Analyst appointed by the Central Government or a State Government under section 33F;

proprietary medicine In relation to Ayurvedic, Siddha or Unani Tibb systems of medicine all formulations containing only such ingredients mentioned in the formulae described in the authoritative books of Ayurveda, Siddha or Unani Tibb systems of medicine specified in the First Schedule, but does not include a medicine which is administered by parenteral route and also a formulation included in the authoritative books as specified in clause Insertion of new Third Schedule Insertion of new Chapter IA No clinical trial without permission Medical treatment and compensation for injury or death due to clinical trial. Registration of Ethics Committee. Disclosure of name, address, etc. of persons involved in clinical trials Penalty for repeat offence are addedPenalty for violation of conditions of permission

Insertion of new section 5A. Constitution of Medical Devices Technical Advisory Board. Substitution of new section for section 7. Drug, Cosmetic and Medical Devices Consultative Committee. Insertion of new Chapter IIA. IMPORT, MANUFACTURE, SALE AND DISTRIBUTION OF NOTIFIED CATEGORY OF MEDICAL DEVICE.Insertion of new section 9E. Substitution of new section for section 13. Substitution of new section for section 23. Substitution of new section for section 25. Report of Government Analyst. Insertion of new sections 33Q, 33R, 33S and 33T.

Amendment of section

Amendment of section 5Amendment of section 6Amendment of section 9B. Amendment of section 10. Amendment of section 11. Amendment of section 17B. Amendment of section 18A. Amendment of section 18B. Amendment of section 19. Amendment of section 20. Amendment of section 21. Amendment of section 22. Amendment of section 24.Amendment of section 26. Amendment of section 26A. Amendment of section 27.

Amendment of section 28A. Amendment of section 28B. Amendment of section 29Amendment of section 30. Amendment of section 30A.Amendment of section 31A. Amendment of section 31B. Amendment of section 32Amendment of section 34A. Amendment of section 34AA. Amendment of section 34AAAAmendment of section 35A. Amendment of section 35B. Amendment of section 39.

THE THIRD SCHEDULE (See sub-section (6) of section 18) CATEGORIES OF DRUGS FOR WHICH THE CENTRAL LICENSING AUTHORITY IS EMPOWERED TO ISSUE LICENCE AND PERMISSION.

1. antigens and anti-toxins; 2. blood products; 3. cytotoxic substances (anti-cancer drugs); 4. drug products containing modified living organisms; 5. fixed dose combination. 6. gene therapeutic products; 7. hormones and preparations containing hormones; 8. large volume parenterals; 9. monoclonal anti-bodies; 10. recombinant-deoxyribo nucleic acid derived drugs; 11. ribo nucleic acid derived drugs; 12. sera; 13. solution of serum proteins intended for injection; 14. stem cells and cell based drug products; 15. toxins; 16. vaccines; 17. xenografts;

References:www.cdsco.nic.inForensic pharmacy, kolate CK and Gokhle SB, Pharma book Syndicate; 152Dr. D.R Lohars book of Legal status of Ayurvedic, Siddha and Unani Medicines.