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Provisions for manufacturing of drugs for examination, test or analysis are provided under Part-VIII under Drugs & Cosmetics Rules, 1945 from Rule 86 to 93.
The opening line of
Rule-86: Conditions relating to manufacture for examination, test or analysis –
“The provisions of Section 18 of the Act shall not apply to the manufacture of any drug in small quantities for the purpose of examination, test or analysis if the conditions prescribed in this Part are fulfilled.”
This provides that Section 18 of the Drugs Act shall not apply to the manufacturing of drugs for examination, test or analysis, therefore, if any person found manufacturing a drug in small quantity for examination, test or analysis cannot be prosecuted for contravention of provisions of Section 18 of Drugs Act especially 18(c) punishable under Section 27(b)(ii) manufacturing of drugs for sale. This has been provided for ‘Ease of Doing Business’ and to encourage the ‘Research & Development in India’. But this opening line made this provision under Part VIII of Drugs Act, almost toothless as person is never having any license. Therefore, question of suspension or cancellation of license doesn’t arise. It may attract only contravention of rules and punishment u/s 27(d) of Drugs Act.
Rule 87 & 88:
Rules 87 & 88 provide labeling provisions for drugs manufactured for examination, test or analysis which provides that label must indicate the purpose for which it has been manufactured and Rule 88 provides labeling of drugs supplied to other person. Then it mandates that
“The accepted scientific name of the substance if known, or if not known a reference which will enable the substance to be identified and the purpose for which it has been manufactured. ”
But Rule 88 is silent about the consideration of purpose for which this drug can be supplied to other person. If it is sold by person who has manufactured this drug for examination, test or analysis to other person then it should attract Section-18 of Drugs Act as it becomes manufacturing for sale and further may be for examination, test or analysis etc.
Application on Form-29 read with Rule 89: ‘License to manufacture drugs for the purpose of examination, test or analysis’ and Form-30 read with Rule-90: ‘Application for license to manufacture drugs for the purpose of examination, test or analysis’, both applications are to be made by a person and license is to be issued to a person for manufacturing of drugs exclusively for examination, test or analysis at the place specified in license on Form-29 (as provided in Rule-92). But this Rule-92: ‘condition of license’ does not provide any minimum requirement for area, building, machinery for manufacturing of drugs for examination, test or analysis.
Rule 89: provides as under:
“Provided that in the case of a drug the composition of which is such that the drug is not generally recognized among experts qualified by scientific training and experience to evaluate the safety of drugs as safe for use, no licence in Form 29 shall be granted unless the applicant produces a certificate from the ―Licensing Authority mentioned in Rule 21, to the effect that there would be no objection to such licence being granted.”
This shows that approval for grant of license on Form-29 can be granted by State Licensing Authority (SLA), if the drug is generally recognized among experts qualified by Scientific Training and Experience to evaluate the safety of drugs as ‘safe for use’. If a drug is not at all recognized then only NOC from DCG(I)/CLAA (Central Licensing Approval Authority) is required. Here the scope for grant of approval of manufacturing for examination, test or analysis by State Licensing Authority is much wider than on any other license e.g. on Form 25 or 28 no new drug can be considered for approval by State Licensing Authority.
Rule 90(2): Prescribes that
“Every application on Form-29 shall be accompanied by a fee of Rs. 250/-.”
But it does not specify that how many items under one application can be applied as it is clear beyond that in case of product approval on Form 25 and Form 28 a fee of Rs. 300/- per product is required as provided in Rules.
Rule 91: Prescribes as under:
“Duration of licence – A licence in Form 29 shall, unless sooner cancelled, be in force for a period of one year from the date of issue, and may thereafter be renewed for periods of one year at a time.”
This shows that grant of approval for manufacturing for examination, test or analysis is for three years as per notification GSR 103(E) dated 02.02.2017 whereas renewal of this approval for manufacturing for examination, test or analysis is only for one year.
After perusal of these provisions following questions arise which need to be addressed:-
1. To make this Part-VIII – manufacturing for examination, test or analysis more properly enforceable more penalty/punishment provisions are required to be provided as provisions of Section 18 do not apply to these provisions.
2. More proper labeling provisions may be designed and prescribed under these Rules to stop/check misuse of drugs manufactured for examination, test or analysis.
3. Since scope of grant of approval of products by State Licensing Authority is much wider, therefore, provisions of NOC by DCG(I) or CLAA may be dispensed with.
4. In Rule 90(2) word ‘application’ may be replaced with word ‘Drug Product’ and a fee of Rs. 250/- may be charged for every product not Rs. 250/- with application having many products.
5. In Rule 91, in the era of perpetuity of licenses and retention by applicants, applicants may be allowed to retain the drug products approvals for manufacturing for examination, test or analysis.
6. A schedule may be appended to these rules providing minimum requirements of area, building, machinery, equipments, personnel, procedures for Pilot Plants required for manufacturing of drugs for examination, test or analysis and provision “Good Manufacturing Practices” must be provided as now Form-29 is became necessary for approval of product on Form-25 and Form-28 etc. for conduct and stability studies.
7. “Good Manufacturing Practices” (GMP) provisions are required as these drugs also further used for conducting clinical trials and to be given to human subjects and any drug for consumption of human being should be manufactured under GMP conditions.
8. For making GMP requirements report of sub-committee of DCC in Formulation Development may be used and WHO standards for manufacturing of investigational products for clinical studies (World Health Organization Technical Report Series No. 863 of 1996) of solid oral dosage form i.e. including all types of non beta-lactum tablets, capsules, powder for suspension and granules.
Therefore, provisions of Part VIII – manufacturing for purpose of examination, test or analysis needs to be revised in view of the fact that approval on Form 29 became essential requirement to conduct stability studies of products to be considered for approval on Form-25 and 28 and firms are obtaining approvals on Form 29 after obtaining permission on various clinical trial forms form DCG(I) under New Drugs and Clinical Trial Rules.
Disclaimer: This is personal opinion of the writer and anyone may have a different opinion about this article and will not attract any legal implication.