D & c act

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MR. VINOD GANGADHAR TONDE

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

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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

1945 – Rules under the Act

Extended to whole of India……3

LIST OF AMENDING ACTS AND ADAPTATION

ORDERS-------- (correct, improve)

1. The Drugs (Amendment) Act, 1955



4. The Drugs and Cosmetics (Amendment) Act, 1964




8. The Drugs and cosmetics (Amendment) Act, 2008

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Objectives To regulate the import, manufacture, distribution

and sale of drugs & cosmetics through licensing.

Manufacture, distribution and sale of drugs andcosmetics 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 AdvisoryBoard(DTAB) and Drugs ConsultativeCommittees(DCC) for Allopathic and allied drugsand cosmetics.

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Definitions Drug

Cosmetics

Misbranded Drug

Adulterated Drug

Spurious Drug

Manufacture

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Definitions

Drugs :All medicines for internal or external use of

human beings or animals and all substancesintended to be used for or in the diagnosis,treatment, mitigation (suppression) or preventionof any disease or disorder in human beings oranimals, including preparations applied on humanbody for the purpose of repelling insects likemosquitoes.

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Such substance (other than food) intended to affect the structure or any other function of the human body or intended to be used for destruction of vermin or insects which cause disease in the human beings or animals.

All the substances intended for use as components of drug including empty gelatin capsule and,

Such devices intended for internal or external use in diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals.

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Cosmetic :

Any article intended to be rubbed, poured,

sprinkled or sprayed on, or introduced into, orotherwise applied to, the human body or any partthereof for cleansing, beautifying, promotingattractiveness, or altering the appearance, andincludes any article intended for use as acomponent of cosmetic.

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Misbranded drugs :

(a) if it is so coloured, coated, powdered orpolished that damage is concealed or if it is madeto appear of better or greater therapeutic valuethan it really is; or

(b) if it is not labelled in the prescribed manner.

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Adulterated drug :

(a) if it consists, in whole or in part, of any filthy,putrid (dirty) or decomposed substance; or

(b) if it has been prepared, packed or stored underinsanitary conditions whereby it may have beencontaminated with filth or whereby it may havebeen rendered injurious to health; or

(c) if its container is composed in whole or in part,of any poisonous or deleterious substancewhich may render the contents injurious tohealth. 11

If it bears or contains, a colour other than prescribed which may be used for the purpose of colouring only or

If any subsatance mixed with it so as to reduce its quality or strength.

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Spurious drugs : (fake)

(a) if it is imported under a name which belongs toanother drug; or

(b) if it is an imitation of, or a substitute for, anotherdrug or resembles another drug in a manner likelyto deceive or bears upon it or upon its label orcontainer the name of another drug

c) If the label or container of which bears the nameof an individual or company purporting to be themanufacturing of drug, which individual orcompany is fictitious or does not exists.

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Manufacture :In relation to any drug or cosmetic, it

includes any process or part of a process formaking, altering, ornamenting, finishing,packing, labelling, breaking up or otherwisetreating or adopting any drug or cosmetic with aview to its sale or distribution but does notinclude the compounding or dispensing of anydrug, or the packing of any drug or cosmetic, inthe ordinary course of retail business.

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Patent or Proprietary medicine :

A drug which is a remedy orprescription presented in a form ready forinternal or external administration of humanbeings or animals and which is not includedin the edition of the Indian Pharmacopoeiafor the time being or any other Pharmacopoeiaauthorized in this behalf by the CentralGovernment.

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Ayurvedic, Siddha or Unani Drug

I t includes all medicine 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 in accordance with the formula describe in the authoritative books of Ayurvedic, Siddha or Unanisystem of medicine.

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New Drug a) a new substance of chemical, biological or

biotechnological origin; in bulk or prepared dosage form; used for prevention, diagnosis, or treatment of disease in man or animal; which, except during local clinical trials, has not been used in the country to any significant extent; and which, except during local clinical trials, has not been recognized in the country as effective and safe for the proposed claims;

(b) a drug already approved by the licensing authority mentioned in certain claims, which is now proposed to be marketed with modified or new claims, namely, indications, dosage forms (including sustained release dosage form) and route of administration;

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(c) A fixed dose combination of two or more drugs, individually approved earlier for certain claims, which are now proposed to be combined for the first time in a fixed ratio, or if the ratio of ingredients in an already marketed combination is proposed to be changed, with certain claims, viz. indications, dosage form (including sustained release dosage form) and route of administration

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ADMINISTRATIVE BODIES The central government and state government

establish or appoint following bodies for efficient running of the act.

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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

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Under the provision of the act the central Government appoints the drugs Technical Advisory Board to advice the central and state Government on technical matters arising out of the administration of this act, and to carry out the other function assigned to it by this act.

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Drugs Technical Advisory Board(DTAB)- The board consisting of the following members.

Ex-Officio – members

(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

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Nominated:1) Two persons by the Central Government.

2) One person by the Central Government fromthe pharmaceutical industry

3) Two persons holding the appointment ofGovernment Analyst under this Act,

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Elected:

1)one person, to be elected by the Executive Committee of thePharmacy Council of India,

2)one person, to be elected by the Executive Committee of theMedical Council of India,

3)one pharmacologist to be elected by the Governing Body of theIndian Council of Medical Research;

4)one person to be elected by the Central Council of the IndianMedical Association;

5)one person to be elected by the Council of the IndianPharmaceutical Association;

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Functions:To advise the Central Government and the

State Governments on technical matters.

To carry out the other functions assigned to it bythis Act.

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Drugs Consultative Committee(DCC)

It is also an advisory body constituted by centralgovernment.-

to advice the central and state governments and the DrugTechnical Advisory Board on any matter to secureuniformity throughout India in the administration of thisact.

Constitution:

Two representatives of the Central Governmentnominated by central government

One representative of each State Governmentnominated by concerned Government

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There is separate ‘ The ayurvedic, siddha and unanidrugs consultative committee constituted under the act.

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Functions: To advise the Central Government, the State

Governments and the Drugs Technical AdvisoryBoard on any other matter tending to secureuniformity throughout India in theadministration of this Act.

The Drugs Consultative Committee shall meetwhen required

Has power to regulate its own procedure.

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Central Drug Laboratory(CDL) The central government Establishes a central drug laboratory

(calcutta) under the control of Director.

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.

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The functions of the Laboratory in respect of the following drugs or classes of drugs shall be carried out at the Central Research Institute, Kasauli,

The functions of the Director in respect of the said drugs or classes of drugs shall be exercised by the Director of the said

Institute :___(1) Sera(2) Solution of serum proteins intended for injection(3) Vaccines(4) Toxins(5) Antigens(6) Anti-toxins(7) Sterilized surgical ligature and sterilized surgical suture.(8) Bacteriophages

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The functions of the Laboratory in respect of Oral Polio Vaccine shall be carried out by the following Institutes –

(a)Pasteur Institute of India, Coonoor.

(b) Enterovirus Research Centre (Indian Council of Medical Research), Haffkin Institute Compound, Parel, Bombay-400012.]

[(c) The National Institute of Biologicals, NOIDA.]

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The functions of the Laboratory in respect of the following drugs or classes of drugs shall be carried out at the Indian Veterinary Research Institute, Izatnagaror Mukteshwar and the functions of the Director in respect of the said drugs or classes of drugs shall be exercised by the Director of either of the said institutes.

(1) Anti-sera for veterinary use.

(2) Vaccines for veterinary use.

(3) Toxoids for veterinary use.

(4) Diagnostic Antigens for veterinary use

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The functions of the Laboratory in respect of human blood and human blood products including components

to test for freedom of HIV antibodies, shall be carried out by the following Institutes-

(a) National Institutes of Communicable Disease, Department of Microbiology, Delhi.

(b) National Institute of Virology, Pune

(c) Centre of Advanced Research in Virology, Christian Medical College, Vellore

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The functions of the Laboratory in respect of Homoeopathy shall be carried out at the Homoeopathy Pharmacopoeia Laboratory, Ghaziabad.

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The functions of the Laboratory in respect of Blood Grouping reagent and diagnostic kits for Human Immunodeficiency Virus, Hepatitis B Surface Antigen and Hepatitis C Virus shall be carried out at the National Institute of Biologicals, NOIDA.

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Dispatch of samples for test or analysis.

(1) Samples for test or analysis under subsection (4) of Section 25 of the Act shall be sent by registered post in a sealed packet, enclosed, together with a memorandum in Form 1, in an outer cover addressed to the Director.

(2)The packet as well as the outer cover, shall be marked with a distinguishing number.

(3)A copy of the memorandum in Form 1 and a specimen impression of the seal used to seal the packet shall be sent separately by registered post to the Director.

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Recording of condition of seals. On receipt of the packet, it shall be opened by an

officer authorized in writing in that behalf by the Director who shall record the condition of the seal on the packet.

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Report of result of test or analysis. __ After test or analysis the result of the test or analysis, together with full protocols of the tests applied, shall be supplied forthwith to the sender in Form 2.

Fees. __ The fees for test and analysis shall be those specified in Schedule B.

Signature of certificates. __ Certificates issued under these Rules by the Laboratory shall be signed by the Director or by an officer authorized by the Central Government by notification in the official Gazette to sign such certificates.

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Drug control laboratories in stateIn 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 devision:-

Pharmaceutical Chemistry Division

Immunology Division

Pharmacology Division

Pharmacognocy Division

Food Division

Ayurvedic Division

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Function:

Testing of drug sample

Analysis of food sample

Analysis of excise sample

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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 as governmental Analysis for allopathic drugs ;

2 having a degree in medicine, ayurved, 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 government analyst.

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A post graduated degree in medicine or science or pharmacy or pharmaceutical chemistry of a recognized university or has an equivalent qualification recognized and notified by central government for such purpose.

Associated Diploma of the Institution of chemists (India) with Analysis of Drug and pharmaceuticals as one of the subjects and had not less than 3years experience in the testing of drug in labrotary under the control of,

a) A government analyst

b) Head of an Institution or testing laboratory approved for the purpose by the appointing authority or has completed two years training or testing of drugs, including items stated in schedule C in Central Drug Laboratory.

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Duties:

1) The Government Analyst shall cause to be analysed or tested such samples or drugs and cosmetics as may be sent to him by Drug 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.

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Licencing 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 .

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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 licences are being observed;

(3) to procure and send for test or analysis, if necessary, imported packages.

(4) to investigate any complaint.

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(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;

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Procedure on receipt of Sample On receipt of a package of a sample from drug

Inspector, the government analyst compares the seal on the package or on portion of sample or container with specimen impression of the seal received separately and notes condition of seal on the pack or on the portion of sample or container.

On completion of test or analysis he supplied to the inspector a report of analysis in triplicate , together with full protocols of the test applied.

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If purchaser wants to analyze or test drug or cosmetic he has to make an application for test or analysis in form accompanied with prescribed fees and the report of test or analysis of such drug or cosmetic is to be supplied in form by government analyst.

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Drug Inspector A person to be appointed as a Drug Inspector should

have no financial interest in the import, manufacture or sale of the drug or cosmetics,

Drug Inspector is a Public Servant under sec 21 of Indian panel code.

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A person who is appointed an Inspector under the Act

shall be a person who has a degree in Pharmacy or Pharmaceutical Sciences or Medicine with specialization in clinical Pharmacology or Microbiology from a University established in India by law-

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Provided that only those Inspectors: --

(i) Who have not less than 18 months’ experience in the manufacture of atleast one of the substances specified in Schedule C, or

(ii) Who have not less than 18 months’ experience in testing of atleast one of the substances in Schedule C in a Laboratory approved for this purpose by the licensing authority, or

(iii) Who have gained experiences of not less than three years in the inspection of firms manufacturing any of the substances specified in Schedule C during the tenure of their services as Drugs Inspector; shall be authorized to inspect the manufacture of the substances mentioned in Schedule C.

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Qualification of a Licensing Authority No person shall be qualified to be a Licensing

Authority under the Act unless:--

(i) he is a 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) he has experience in the manufacture or testing of drugs or enforcement of the provisions of the Act for a minimum period of five years:

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Controlling authority authority.__(1) All Inspectors appointed by the Central

Government shall be under the control of an officer appointed in this behalf by the Central government and State Government

(2) For the purposes of these rules an officer appointed by the Central Government under sub-rule (1), or as the case may be, an officer appointed by the State Government under sub-rule (2), shall be a controlling authority.

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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.

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Search any person in connection with the offence (fault)

Enter and search at all reasonable times any place or premises in which he has reasoned to believe that an offence is being committed or has been committed

Stop and Search any vehicle or other conveyance which he has reason to believe, used for carrying any drug or cosmetic in respect of which offence has been or has being committed.

Give order in writing to the person in possession of drug or cosmetic in respect of which offence has been committed or is being committed, not to dispose stock of such drug or cosmetic for a specified period not exceeding twenty days or unless the defect may be removed by the possessor of the drug or cosmetic, and may size the stock of such drug or cosmetic or any substance or article employed for commission of offence.

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Examine any record, register, document or any other material object found while exercising above powers and sieze (Catch,hold)) the same if he has reason to believe that it is an evidence of the commission of an offence under the act.

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Penalty for obstructing Inspector If any person willfully obstruct an Inspector in the

exercise of the powers conformed upon him or refuse to produce any record, register or any other document when required or any document when required, he shall be punishable with imprisonment (jail) upto 3 year or with fine or with both.

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Provision of Act

ImportManufacturi

ngSales Labeling

& Packaging

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IMPORT

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For the purpose of import, which is deemed to be the process of a bringing a material from a place outside India to a place in India, a drug are classified below:

A) Drug whose import is prohibited

B) Drug which may be imported under license or permit

C) Drug which can be imported without license

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IMPORT of drugs Classes of drugs prohibited to import

Import of drug under license

1)Specified in Schedule-C/C1

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

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A) Classes of drugs prohibitedto 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 areprohibited in original country, except for the purposeof test, examination and analysis.

Patent/Proprietary medicines whose true formula isnot disclosed.

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B) Drug which may be imported under license or permit

UNDER LICENCE/PERMIT

schedule C/C1 Drugs

Schedule-X drugs

Drugs Imported for examination, test or analysis

Without license

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Import of the biological drugs(C/C1)

Conditions to be fulfillled:

Licensee must have adequate facility for the storage.

Licensee must maintain a record of the sale.

Licensee must allow an inspector to inspect premisesand to check the records.

Licensee must furnish the sample to the authority.

Licensee must not sell drugs from which sample iswithdrawn and he is advised not to sale, and recall thebatch from the market.

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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 even before should not besuspended or cancelled.

The licensee has not been convicted anyoffence under the Drugs and Cosmetics Act orNarcotic and Psychotropic Substances Act.

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Drugs Imported for examination, test or analysisConditions to be fulfilled:

License is necessary under form-11

Must use imported drugs only for said purposeand 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 premisesand check the records.

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Drugs imported for personal useConditions to be fulfilled:

Up to 100 average doses may be importedwithout any permit, provided it is part ofpassenger’s luggage.(articles)

More than 100 doses imported with license.Apply on form no.-12-A,12-B

Drugs must be bonafide personal use.

Drugs must be declared to the customcollectors if so directed.

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Import of drugs without license Substances not used for medicinal purpose

Drugs in Sch-C1 required for manufacturing and not formedicinal use.

Substances which are both drugs and foods such as:

Condensed/Powdered Milk

Malt

Lactose

Farex/Cereal

Oats

Predigested foods

Ginger, Pepper, Cumin, Cinnamon

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Penalties related to ImportOFFENCES PENALTIES

Import of spurious ORadulterated drug OR drug whichinvolves risk to human beings oranimals OR drug not havingtherapeutic values

a) 3 years imprisonment and5000 Rs. fine on firstconviction

b) 5 years imprisonment OR1000 Rs. fine OR both forsubsequent conviction

Contravention of the provision a) 6 months imprisonment OR500 Rs. fine OR both for firstconviction

b) 1 year imprisonment OR 1000Rs. fine for subsequentoffence

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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 ppmlead, 100 ppm heavy metals

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MANUFACTURE

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Manufacture --------- ? Manufacture of drug is a totally controlled process

and drug can be manufactured and under license subject to following :

i) Infrastructure facilities

ii) Technical Manpower

iii) Analytical Labrotaries

iv) Records

v) Inspection and sampling of drug

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Manufacture Kind of License – For the manufacturing of drugs

the following categories of licenses can be granted.

Licence for

Manufacture of Sch-C and C1 drug

Manufacture of Sch-X drugs

Manufacture of other than in Sch X and Sch-C/C1

Loan license

Drug meant for examination , test or analysis

Repackaging license

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Manuf. of drugs those in Schedule-C/C1(Biological)

Conditions:

Drugs must be issued in previously sterilized sealedglass or suitable container

Containers should comply with Sch-F

Some classes tested for aerobic & anaerobic micro-organism.eg. Sera ,Insulin, Pituitary hormones.

Serum tested for abnormal toxicity

Parentral in doses of 10 ml or more should be tested forfreedom from Pyrogens

Separate lab. for culture & manipulation of sporebearing Pathogens

Test for sterility should be carried out.

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Manufacture Of Sch-X drugs

Conditions:

Accounts of all transactions regarding manuf. shouldbe maintained in serially.(Preserved for 5 years)

Have to sent invoice of sale to licensing authority every3 months

Store drugs in direct custody of responsible person.

Marketed in packings not exceeding

100 unit dose –Tablets/Capsules

300 ml- Oral liquid

5 ml - Injection

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Manuf. of drugs other than in Sch-C/C1

Conditions:

Premises should comply with schedule ‘M’

Adequate facility for testing, separate frommanufacturing

Adequate storage facility

Records maintained for at least 2 years from date ofExp.

Should provide sample to authority

Furnish data of stability

Maintain the inspection book

Maintain reference samples from each batch

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Loan LicenseDefinition:

A person(applicant) who does not have hisown arrangements(factory) for manufacture butwho wish to manufacturing facilities owned byanother licensee. Such licenses are called Loanlicenses.

Loan licenses are issued for:

1) Drugs other than specified in C/C1 & X.

2) Drugs specified in Schedule-C/C1

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Drug meant for examination , test or analysis Adequate space , well lighted and ventilated or if the need

be air-conditioned should be provided commensurate with the nature and number of samples

Where animals are used for testing an adequate well lighted and ventilated animal house should be provided and the animal housed hygienically, proper arrangement should be made for quarantining and periodic examination of animals and preparation of animal feeds.

In general, compliance with the provision of the prevention of cruelty of animals should be ensured

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The test should be done by or under the supervision of qualified and experience person

Books of standards and reference literature needed for testing and analysis should be provided.

Adequate facilities should be provided for proper storage of samples.

Record of analysis should be maintained for at least 2 years for drugs with expiry dates and at least for 6 yrfor other.

Report of analysis should be furnished in prescribed form.

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Repackaging licenseDefinition:

Process of breaking up any drug from a bulk

container into small packages and labeling with aview to their sale and distribution.

Repackaging of drugs is granted of drugs other thanSchdule-C/C1 and X.

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Prohibition of manufacture Drug not of standard quality or misbranded,

adulterated or spurious.

Patent or Proprietary medicine

Drugs in Sch-J

Risky to human beings or animals

Drugs without therapeutic value

Preparation containing cyclamates(artificialsweetener )

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Penalties related to Manufacture

OFFENCES PENALTIES

Manufacture of any spurious drugs a) 1-3 years imprisonment andRs.5000 fine

b) 2-6 years imprisonment &Rs.10000 fine on subsequentconviction

Manufacture of adulterated drugs a) 1 year imprisonment & Rs.2000fine

b) 2 years imprisonment &Rs.2000 fine for subsequentconviction

Manuf. of drugs in contravention ofthe provisions

a) Imprisonment up to 3 months &Rs.500 fine

b) Imprisonment up to 6 months& Rs.1000 fine on subsequentconviction

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Manufacture of cosmeticsProhibited for the following classes of drug:

Misbranded or spurious cosmetics and of substandardquality

Cosmetics containing hexachlorophene or mercurycompounds

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

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SALE

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Sale of Drugs

Classes of drugs prohibited to be sold

Wholesale of biological (C/C1)

Wholesale of other than those specified in C/C1

and X

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Class of drug prohibited to sale

Misbranded, spurious, adulterated and drugs notof standard quality

Patent/Proprietary drugs with undisclosed formula

Sch-J drugs

Expired drugs.

Drugs used for consumption by governmentschemes such as, Armed force.

Physician’s samples

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Wholesale of biological (C/C1) Adequate premises, with greater than 10 M2

area, with proper storage facility

Drugs sold only to retailer having license

Premises should be in charge of competentperson who is Reg. Pharmacist.

Records of purchase & sale

Records preserved for 3 years from date of sale

License should displayed on premises

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whole sale from other than specified in c/c1 and x

All the conditions as discussed in for biological.

Compounding is made by or under the direct andpersonal supervision of a qualified person.

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Labeling & PackagingAll the general and specific

labeling and packagingspecified to all classes ofdrugs and cosmetics shouldbe as per the provisions madeunder the act.

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Labelling Name of drug

Net content

Content of API

Name & address of the manufacturing

Batch no.

License no.

Date of mfg

Date Exp

% Alcohol

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For allopathy

Label ?

Ophthalmic

Animal

Disinfectant

Colored medicine

Vaccines

Oral

External

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allopathy.docx

For ayurvedic, siddha, unanihomoepathy and cosmetics

LABEL

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sidhha unani ayurvedic.docx

Export According to the country of Export

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Schedules to the act

First schedule – Names of books underAyurvedic and Siddha systems

Second schedule – Standard to be compliedwith by imported drugs and by drugsmanufactured for sale, sold, stocked or exhibitedfor sale or distribution

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Schedules to the rulesTYPE CONTENT

“A” Performa for forms( 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) applicableto special provisions.

“C1” List of Biological and special products (nonparenteral)applicable to special provisions.

“D” List of drugs that are exempted from provisions of import

“E1” List of poisonous substances under the Ayurvedic , Siddha andUnani systems

“F” Provisions applicable to blood bank

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“F1” Special provision applicable to biological and special products, eg.Bacterial and viral vaccines, sera from living animals, bacterialorigin diagnostic agents

“F2” Standards for surgical dressings

“F3” Standards for umbilical tapes

“FF” Standards for ophthalmic preparations

“G” List of substances required to be used under medicalsupervision and labelled accordingly

“H” List of substances (prescription) that should be sold by retail onlyon prescriptions of R.M.P.

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“J” List of diseases and ailments that drug should not claim to cure

“K” List of drugs that are exempted from certain provisions regardingmanufacture

“M” Requirements of manufacturing premises, GMP requirements of factory premises, plants and equipments

“M1” Requirements of factory premises for manufacture of Homeopathic medicines

“M2” Requirements of factory premises for manufacture of cosmetics

“M3” Requirements of factory premises for manufacture of medical devices

“N” List of equipment to run a Pharmacy

“O” Standards for disinfectant fluids

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TYPE CONTENT

“P” Life period(expiry) of drugs

“Q” Coal tar colors permitted to be used in cosmetics

“R” Standards for mechanical contraceptives

“R1” Standards for medical devices

“S” Standards for cosmetics

“T” Requirements (GMP) of factory premises for Ayurvedic, Siddha, Unani drugs

“U” Manufacturing and analytical records of drugs

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“U1” 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

“Y” Requirement and guidelines on clinical trials for import andmanufacture of new drugs

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Drugs and Cosmetics (Amendment) Act, 2008

Salient features of the Act:-

Substantial enhancement in punishment

Life imprisonment for offenders involved inmanufacture, sale and distribution of spuriousand adulterated drug likely to cause grievoushurt

Minimum punishment of seven years whichmay extend to life imprisonment

Provision for compensation to affected person

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References

101

102

D & c act

Law

drugs cosmetics act

drugs amendment act

sale of drugs cosmetics

cosmetics amendment

misbranded drugs

allied drugs

unani drugs

rulesrecent amendment