Dr. Sitaram Dixit

An Act to regulate the import, export, manufacture, distribution and sale of drugs, cosmetics and medical devices to ensure their safety, efficacy, quality and conduct of clinical trials and for matters connected therewith or incidental hereto. WHEREAS it is expedient to regulate the import, export, manufacture, distribution and sale of drugs, cosmetics and medical devices to ensure their safety, efficacy, quality and conduct of clinical trials and for matters connected therewith or incidental thereto. AND WHEREAS the Legislature of all the Provinces have passed resolutions in terms of section 103 of the Government of India Act, 1935 (26 Geo. 5, c. 2), in relation to such of the above-mentioned matters and matters ancillary there to as are enumerated in List II of the Seventh Schedule to the said Act; The provisions of this Act shall be in addition to and not in derogation of, the Narcotic Drugs and Psychotropic Substances Act, 1985 and any other law for the time being in force.

[(i) 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;] (ii) Such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of [vermin]or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette;] [(iii) All substances intended for use as components of a drug including empty gelatin capsules; and (iv) Such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as maybe specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board;]

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 inhuman 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;]

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

manufacture in relation to any drug [or cosmetic] includes any process or part of a process for making, altering, ornamenting, finishing, packing, labeling, 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; and to manufacture shall be construed accordingly;] to import, with its grammatical variations and cognate expressions means to bring into [India];

patent or proprietary medicine means, 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 (a); In relation to any other systems of 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 be half by the Central Government after consultation with the Drugs Technical Advisory Board constituted under section 5;] 3 [ 2 [(i)] prescribed means prescribed by rules made under this Act.]

Misbranded Cosmetics: a cosmetic shall be deemed to be misbranded (a) if it contains a color which is not prescribed; or (b) if it is not labeled in a prescribed manner; or (c) if the label or container or anything accompanying the cosmetic bears any statement which is false or misleading in any particular. Spurious Cosmetics: a cosmetic shall be deemed to be spurious, (a) if it is imported under the name which belongs to another cosmetic; or (b) if it is an imitation of, or is a substitute for, another cosmetic or resembles another cosmetic in a manner likely to deceive or bears upon it or upon its label or container the name of another cosmetic, unless it is plainly or conspicuously marked so as to reveal its true character and its lack of identity with such other cosmetic; or (c) if the label or the container bears the name of an individual or company purporting to be the manufacturer of the cosmetic, which individual or company is fictitious or does not exist; or (d) if it purports to be the product of a manufacturer of whom it is not truly a product.

Disclosure of the name of the manufacturer, etc. Every person, not being the manufacturer of a drug or cosmetic or his agent for the distribution there of, shall, if so required, disclose to the Drugs Control Officer the name, address and other particulars of the person from whom he acquired the drug or cosmetic. Maintenance of records and furnishing of information. Every person holding a license, under clause (c) of section 18 shall keep and maintain such records, registers and other documents as maybe prescribed and shall furnish to any officer or authority exercising any power or discharging any function under this Act such information as is required by such officer or authority for carrying out the purposes of this Act.

Penalty for manufacture, sale, distribution, stocks or exhibits or offers for sale. Penalty for non-disclosure of the name of the manufacturer, etc. Penalty for not keeping documents, etc., and for non- disclosure of information without reasonable cause or excuse, Penalty for manufacture, etc., of drugs or cosmetics in contravention of section 26 A (Risk to Public). Penalty for use of Government Analysts report for advertising.

Prohibition of sale or distribution. Subject to other provisions of these rules, no person shall sell or distribute any cosmetic unless the cosmetic, if of Indian origin is manufactured by a licensed manufacturer and labeled and packed in accordance with these rules. Exemption of cosmetics not manufactured for consumption or sale in India from the provisions of this Part. Labels on packages or containers of cosmetics not manufactured for consumption or sale in India shall be adopted to meet the specific requirements, if any, of the consignee: Provided that where a cosmetic is required by the consignee to be not labeled with the name and address of the manufacturer, the labels on packages or containers shall bear a code number as approved by the Licensing Authority mentioned in rule 21.

Manner of labeling. Subject to other provisions of the rules, a cosmetic shall carry.– (1) on both the inner and outer labels; (a) the name of the cosmetic, (b) the name of the manufacturer and complete address of the premises of the manufacturer where the cosmetic has been manufactured. Provided that if the cosmetic is contained in a very small size container where the address of the manufacturer cannot be given, the name of the manufacturer and his principal place of manufacture shall be given along with pin code. (2) On the outer label.– A declaration of the net contents expressed in terms of weight for solids, fluid measure for liquids, weight for semi-solids, combined with numerical count if the content is sub-divided: Provided that this statement need not appear in case of a package of perfume, toilet water or the like the net content of which does not exceed 60 ml or any package of solid or semisolid cosmetic the net content of which does not exceed 30 grams.

(3) on the inner label, where a hazard exists– (a) adequate direction for safe use, (b) any warning, caution or special direction required to be observed by the consumer, (c) a statement of the names and quantities of the ingredients that are hazardous or poisonous. (4) 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 figures representing the batch number being preceded by the letter B, provided that this clause shall not apply to any cosmetic containing 10 grams or less if the cosmetic is in solid or semi-solid state, and 25 milliliters or less if the cosmetic is in a liquid state: [Provided further that in the case of soaps, instead of the batch number, the month and year of manufacture of soap shall be given on the label.] (5) manufacturing licence number, the number being preceded by the letter M. (6) Where a package of a cosmetic has only one label, such label shall contain all the information required to be shown on both the inner and the outer labels, under these Rules.

Prohibition against altering inscriptions on containers, labels or wrappers of cosmetics. No person shall alter, obliterate or deface any inscription or mark made or recorded by the manufacturer on the container, label or wrapper of any cosmetic: Provided that nothing in this rule shall apply to any alteration, inscription or mark made on the container, label or wrapper of any cosmetic at the instance or direction or with the permission of the licensing authority. Special provisions relating to toothpaste containing fluoride. (i) Fluoride content in tooth paste shall not be more than 1000 ppm and the content of fluoride in terms of ppm shall be mentioned on the tube and carton.] (ii) Date of expiry should be mentioned on tube and carton.] Report of result of test or analysis of cosmetics. Test reports on samples of cosmetics taken for test or analysis under these rules shall be supplied in Form 34. Standard for cosmetics. Subject to the provisions of these rules, the standards for cosmetics shall be such as may be prescribed in Schedule S.

Hair dyes containing Para-Phenylenediamine or other Dyes, Colors and Pigments, shall be labeled with the following legend in English and local languages and these shall appear on both the inner and the outer labels. CautionThis product contains ingredients which may cause skin irritation in certain cases and so a preliminary test according to the accompanying direction should first be made. This product should not be used for dyeing the eye-lashes or eye-brows; as such a use may cause blindness. Each package shall also contain instructions in English and local languages on the following lines for carrying out the test: This preparation may cause serious inflammation of the skin in some cases and so a preliminary test should always be carried out to determine whether or not special sensitivity exists. To make the test, cleanse a small area of skin behind the ear or upon the inner surface of the forearm, using either soap and water or alcohol. Apply a small quantity of the hair dye as prepared for use to the area and allow it to dry. After twenty- four hours, wash the area gently with soap and water. If no irritation or inflammation is apparent, it may be assumed that no hypersensitivity to the dye exists. The test should, however, be carried out before each and every application. This preparation should on no account be used for dyeing eyebrows or eye-lashes as severe inflammation of the eye or even blindness may result.

Application for grant of testing drugs/cosmetics : Application for grant or renewal of approval for carrying out tests for identity, purity, quality and strength on drugs or cosmetics or the raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of drugs or cosmetics, shall be made in Form 36 to the Licensing Authority appointed by the State Government for the purposes of Part VII, VII (A) or XIV of these Rules, as the case may be and referred to as the approving authority under this Part and shall be accompanied by an inspection fee. Provided that the applicant shall furnish to the approving authority such additional information as may be required by him in connection with the application in Form 36: ExplanationFor the purpose of this Part, the words drugs and cosmetics shall also mean and include the raw materials used in the manufacture of drugs including Homoeopathic drugs or cosmetics, as the case maybe

(1) The premises where the tests are being carried out shall be well lighted and properly ventilated except where the nature of tests of any drug or cosmetic warrants otherwise. Wherever necessary, the premises shall be air conditioned so as to maintain the accuracy and functioning of laboratory instruments or to enable the performance of special tests such as sterility tests, microbiological tests, etc. (2) The applicant shall provide adequate space having regard to the nature and number of samples of drugs or cosmetics proposed to be tested. Provided that the approving authority shall determine from time to time whether the space provided continues to be adequate. (4) The applicant shall provide and maintain suitable equipment having regard to the nature and number of samples of drugs or cosmetics intended to be tested which shall be adequate in the opinion of the approving authority. (5) The testing of drugs or cosmetics, as the case may be, shall be under the active direction of a person whose qualifications and experience are considered adequate in the opinion of the approving authority and who shall beheld responsible for the reports of test or analysis issued by the applicant.

(3) If it is intended to carry out tests requiring the use of animals, the applicant shall provide for an animal house and comply with the following requirements, (a) The animal house shall be adequate in area, well lighted and properly ventilated and the animals undergoing tests shall be kept in air conditioned area. (b) The animals shall be suitably housed in hygienic surroundings and necessary provisions made for removal of excreta and foul smell. (c) The applicant shall provide for suitable arrangements for preparation of animal feed. (d) The applicant shall provide for suitable arrangements for quarantining of all animals immediately on their receipt in the institution. (e) The animals shall be periodically examined for their physical fitness. (f) The applicant shall provide for isolation of sick animals as well as animals under test. (g) The applicant shall ensure compliance with the requirements of the Prevention of Cruelty to Animals Act, 1960 (59 of 1960). (h) The applicant shall make proper arrangements for the disposal of the carcasses of animals in a manner as not to cause hazard to public health.

(6) The testing of drugs or cosmetics, as the case may be, for identity, purity, quality and strength shall be carried out by persons whose qualifications and experience of testing are adequate in the opinion of the approving authority. (7) The applicant shall provide books of standards recognized under the provisions of the Act and the Rules made there under and such books of reference as may be required in connection with the testing or analysis of the products for the testing of which approval is applied for. Duration of approval. An approval granted in Form 37 or renewed in Form 38, unless sooner suspended or withdrawn, shall be [valid for a period of five years on and from the date on which] it is granted or renewed: Provided that if an application for the renewal of an approval in Form 37 is made before its expiry or if the application is made within six months of its expiry after the payment of the additional fee, the approval shall continue to be in force until orders are passed on the applications and the approval shall be deemed to have expired if the application for its renewal is not made within six months of its expiry

(a) The institution granted approval under this Part (hereinafter referred to as the approved institution) shall provide and maintain an adequate staff and adequate premises and equipment as specified in rule 150-C. (b) The approved institution shall provide proper facilities for storage so as to preserve the properties of the samples to be tested by it. (c) The approved institution shall maintain records of tests for identity, purity, quality and strength carried out on all samples of drugs or cosmetics and the results thereof together with the protocols of tests showing the readings and calculation in such form as to be available for inspection and such records shall be retained in the case of substances for which an expiry date is assigned for a period of two years from the expiry of such date and in the case of other substances for a period of six years.

(d) The approved institution shall allow the Drugs Control Officer appointed under this Act to enter with or without prior notice the premises where the testing is carried on and to inspect the premises and the equipment used for test and the testing procedures employed. The institution shall allow the Drugs Control Officers to inspect the registers and records maintained under these Rules and shall supply to such Drugs Control Officers such information as they may require for the purpose of ascertaining whether the provisions of the Act and Rules made there under have been observed. (e) The approved institution shall from time to time report to the approving authority any changes in the person-in-charge of testing of drugs or cosmetics or in the expert staff responsible for testing as the case may be and any material alteration in the premises or changes in the equipment used for the purposes of testing which have been made since the date of last inspection made on behalf of the approving authority before the grant or renewal of approval.

(f) The approved institution shall furnish reports of the results of test or analysis in Form 39. (g) In case any sample of a drug or a cosmetic is found on test to be not of standard quality, the approved institution shall furnish the approving authority [and the licensing authority of the State where the manufacturer and/or sender of the drug or cosmetic is located] with copy of the test report on the sample with the protocols of tests applied. (h) The approved institution shall comply with the provisions of the Act and Rules made there under and with each further requirements, if any, may be specified in the rules subsequently made under Chapter IV of the Act of which the approving authority has given the approved institution not less than four months notice. (i) The approved institution shall maintain an Inspection Book to enable the Drugs Control Officers to record his impression or defects noticed.

Inspection before grant of approval. Before an approval in Form 37 is granted, the approving authority shall cause the institution at which the testing of drugs or cosmetics, as the case may be, is proposed to be carried out to be inspected jointly by the Drugs Drugs Control Officers of the Central Drugs Standard Control Organization and the State Drugs Control Organization who shall examine the premises and the equipment intended to be used for testing of drugs or cosmetics and inquire into the professional qualifications of the expert staff to be employed. Report of Inspection. The Drug Drugs Control Officer mentioned in rule 150-F shall forward to the approving authority a detailed report of the result of the inspection.

Procedure of approving authority. (1) If the approving authority after such further enquiry, if any, as he may consider necessary, is satisfied that the requirements of the rules made under the Act have been complied with and that the conditions of the approval and the rules made under the Act will be observed, he shall grant an approval in Form 37. (2) If the approving authority is not so satisfied, he shall reject the application and shall inform the applicant of the reasons for such rejection and of the conditions which must be satisfied before an approval could be granted. Further application after rejection. If within a period of six months from the rejection of an application for approval, the applicant informs the approving authority that the conditions laid down have been satisfied and deposits inspection fee of the approving authority may, if, after causing a further inspection to be made, he is satisfied that the conditions for grant of approval have been complied with, grant the approval in Form 37.

Renewal: On an application being made for renewal the approving authority may cause an inspection to be made and if satisfied that the conditions of the approval and the rules made under the Act are and shall continue to be observed shall issue a certificate of renewal in Form 38. Withdrawal and suspension of approvals (1) The approving authority may, after giving the approved institution an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefore, withdraw an approval granted under this Part or suspend it for such period as he thinks fit either wholly or in respect of some of the categories of drugs or items of cosmetics to which it relates, if in his opinion the approved institution has failed to comply with any of the conditions of the approval or with any provisions of the Act or the Rules made there under. (2) Any approved institution whose approval has been suspended or withdrawn may within three months of the date of the order appeal to the State Government which shall dispose of the appeal in consultation with a panel of competent persons appointed by it in this behalf and notified in the Official Gazette.

Clinical Trials Ethics Committee Imports