REPACKING OF DRUGS
Important Laws
- Drugs and Cosmetics Rules, 1945
- Drugs and Cosmetics Act, 1940
Repacking of Drugs – Allowed (After Obtaining a license).
Drugs – Repacking can be done only for which the license is granted.
Repacking will fall under the category of manufacturing – Section 3 (f)
Drugs and Cosmetics Rules, 1945 – [Important Rules – 69, 70, 71(A), 72, 74(A)]
Rule 69 – Application for licence to manufacture drugs other than those specified in Schedules C and C(1) to the Drugs and Cosmetics Rules – (1) Application for grant or renewal of licence to manufacture for sale [or for distribution] of drugs, other than those specified in Schedules C and C(1) shall be made to the licensing authority appointed by the State Government for the purpose of this Part (hereinafter in this Part referred to as the licensing authority) and shall be made –
(a) in the case of repacking of drugs excluding those specified in Schedule X for sale or distribution in Form 24-B;
Explanations – For the purpose of these rules, the term ‘repacking’ means the process of breaking up any drug from a bulk container into small packages and the labelling of each such package with a view to its sale and distribution, but does not include the compounding or dispensing or the packing of any drug in the ordinary course of the retail business.
Rule 70 – Form of licence to repack or manufacture drugs other than those specified in Schedules C and C(1) – Licences for repacking of drugs against application in Form 24-B shall be granted in Form 25-B, licences for manufacture of drugs included in Schedule X against application in Form 24-F shall be granted in Form 25-F and licences for manufacture of drugs against application in Form 24 shall be granted in Form 25.
Rule 71(A) – Conditions for the grant or renewal of a licence in Form 25-B – Before a licence in Form 25-B is granted or renewed the following conditions shall be complied with by the applicant-
(1) the repacking operation shall be carried out under hygienic conditions and under the supervision of a competent person;
(2) the factory premises shall comply with the conditions prescribed in Schedule M; and] (3) the applicant shall have adequate arrangements in his own premises for carrying out tests for the strength, quality and purity of the drugs at a testing unit which shall be separate from the repacking unit : Provided that the repacking units, which, before the commencement of the Drugs and Cosmetics (Second Amendment) Rules, 1977, were making arrangements with institutions approved by the licensing authority for such tests to be carried out on their behalf, may continue such arrangement up to the 31st July, 1977 :
Rule 72 – Duration of licence – An original licence or a renewed licence in Form 25,[Form25-B or Form 25-F]unless sooner suspended or cancelled shall be valid for a period of five years on and from the date on which it is granted or renewed:
Rule 74 (A) – Conditions for licence in Form 25-B – A licence in form 25-B shall be subject to the conditions stated therein and to the following conditions- (a) the repacking of drugs shall at all times be conducted under the personal supervision of atleast one person who is approved as a competent person bythe licensing authority; (b) the licensee shall either provide and maintain adequate arrangements in his own premises for carrying out tests of the strength, quality and purity of the drugs repacked or make arrangements with some intitution approved by the licensing authority 51 [under part XV(A) of the Rules] for such tests to be regularly carried out on his behalf by the institution;
(e) the licensee shall allow an [Inspector appointed under the Act ] to enter with or without notice,any premises where the repacking of drugs in respect of which the licence is issued is carried on, to inspect the premises and to take samples of repacked drugs;
(f) the licensee shall, either in his own laboratory or, in any other laboratory approved by the licensing authority, test each batch or lot of raw material used by him for repacking and also each batch of the product thus repacked and shall maintain records or registers showing the particulars in respect of such tests as specified in Schedule U. The records or registers shall be retained for a period of five years from the date of repacking. The licensee shall allow the Inspector to inspect all registers and records maintained under these rules and shall supply to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and these rules have been observed;
Drugs and Cosmetics Rules, 1945 – Important Form
FORM 24-B [See Rule 69] Application for grant or renewal of a licence to repack for sale or distribution of drugs, being drugs other than those specified in Schedules C and C(1) [excluding those specified in Sch. X
FORM 25-B (See Rule 70) Licence to repack for sale or distribution of drugs being drugs other than those specified in Schedules C and C(1) [excluding those specified in Sch. X
FORM 26-B (See Rule 73-B) Certificate of renewal of licence to repack for sale or distribution of drugs being drugs other than those specified in Schedules C and C(1) [excluding those specified in Sch. X]
FORM 39 [See Rule 150-E(f)] Report of test or analysis by approved institution
FORM 50 (See rule 160 D (f)) Report of test or analysis by approved Laboratory
SCHEDULE M PART II – Recommended Equipment
- Repacking of drugs and pharmaceutical chemicals.- The following equipment is recommended for repacking of drugs and pharmaceuticals, chemicals, namely,- (1) Powder disintegrator. (2) Powder sifter (Electrically operated). (3) Stainless steel scoops and vessels of suitable sizes. (4) Weighing and measuring equipment. (5) Filling equipment (semi-automatic/automatic machine). (6) Electric sealing machine.
REPACKING ITEMS
Penalty – Drugs and Cosmetics Act, 1940
Section 16 – Standards of quality
Case – The State of Karnataka v. M /s. Vikram Chemical Laboratories No . 1 , IV Main Road , Tata Silk Farm, Bangalore and another (1975) 1 MLJ (Crl) 8 [Imp Para – 2, 11, 12, 13]
– Repacked drugs were of substandard quality and they were held liable for the act.
Section 18 – Prohibition of manufacture and sale of certain drugs and cosmetics – From such date as may be fixed by the State Government by notification in the Official Gazette in this behalf, no person shall himself or by any other person on his behalf—
(c) [manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale,] or distribute any drug [or cosmetic], except under, and in accordance with the conditions of, a licence issued for such purpose under this Chapter:
Case – Rajasthan Pharmaceutical Laboratory, Bangalore and Ors. vs. State of Karnataka (14.01.1981 – SC): MANU/SC/0184/1981 [Imp Para – 1, 2, 3, 6, 11, 12]
– The first appellant holds a licence under the Act for repacking of drugs mentioned in the list which forms part of the licence. For purposes of the Act the first appellant is a manufacturer of the said drugs in view of the definition of the term ‘manufacture’ occurring in Section 3(f) of the Act. On February 27, 1970 on a search of the business premises of the first appellant, a Drugs Inspector seized 42 items of drugs from a room, 33 of which were not in the approved list of drugs appended to the licence issued to the first appellant.
Section 27 – Penalty for manufacture, sale, etc., of drugs in contravention of this Chapter – Whoever, himself or by any other person on his behalf, manufactures for sale or for distribution, or sells, or stocks or exhibits or offers for sale or distributes,—
(ii) without a valid licence as required under clause (c) of section 18, shall be punishable with imprisonment for a term which shall 1 [not be less than three years but which may extend to five years and with fine which shall not be less than one lakh rupees or three times the value of the drugs confiscated, whichever is more]
Cases
Rajasthan Pharmaceutical Laboratory, Bangalore and Ors. vs. State of Karnataka (14.01.1981 – SC): MANU/SC/0184/1981 [Imp Para – 1, 2, 3, 6, 11, 12]
– The first appellant holds a licence under the Act for repacking of drugs mentioned in the list which forms part of the licence. For purposes of the Act the first appellant is a manufacturer of the said drugs in view of the definition of the term ‘manufacture’ occurring in Section 3(f) of the Act. On February 27, 1970 on a search of the business premises of the first appellant, a Drugs Inspector seized 42 items of drugs from a room, 33 of which were not in the approved list of drugs appended to the licence issued to the first appellant.
The State of Karnataka v. M /s. Vikram Chemical Laboratories No . 1 , IV Main Road , Tata Silk Farm, Bangalore and another (1975) 1 MLJ (Crl) 8 [Imp Para – 2, 11, 12, 13]
– Repacked drugs were of substandard quality and they were held liable for the act.
IN VERSUS KANWARLAL ACCUSED LNIND 1974 MAD 110 [Imp para – 2 and 5]
– Repackers come under the purview of the Drugs (Prices Control) Order, 1970.