The Drugs and Cosmetics (10th Amendment) Rules, 2017 dated October 27, 20171 , announced that the manufacturing and sale licenses of drugs once issued shall remain valid forever if the licensee deposits license retention fee every five years, unless the licenses are suspended or cancelled by the Licensing Authority. It also said that, in the case of manufacturing licenses, the premises shall be inspected jointly by the Central and State Drugs Inspectors at least once in three years or as required as per the risk-based approach. With this announcement, the provision of renewal of manufacturing and sale licenses was removed by the Government for ease of continuation of business.
Since then, the Government has received various representations from the State Licensing Authorities regarding certain anomalies in the published rules which were causing difficulties at the implementation level.
Now, therefore, the Central Government, on July 17, 2019, announced the Drugs and Cosmetics (11th Amendment) Rules, 20192 ("Amendment Rule") for having effective implementation of permanency of drugs licenses for manufacturing and sale. The amendment brings the following changes in Drugs and Cosmetics Rule, 1945 ("Rule"):
A. THE BELOW PROVISIONS OF LICENSE RENEWAL/CERTIFICATES OF RENEWAL HAVE BEEN OMITTED BY AMENDMENT RULE:
Rule 150J Renewal i.e., "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."
Form 26J i.e., "Certificate of renewal of loan license to manufacture for sale of Large Volume Parenterals or Sera and Vaccine or recombinant DNA (r-DNA) derived drugs specified in Schedule C and C-1 excluding those specified in Schedule X"
Form 33 i.e., "Certificate of renewal of license to manufacture cosmetics for sale" is omitted in Rule 140 and Rule 143A.
Form 37 [Approval for carrying out tests on drugs/ cosmetics and raw materials used in their manufacture on behalf of licensees for manufacture for sale of drugs /cosmetics.] removes the words "or renewal" from its condition of approvals under Rule 150E.
Form 37 also removes the words "and any certificate of renewal in Form 38 [Certificate of renewal of approval for carrying out tests on drugs/ cosmetics and raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of drugs/ cosmetics]" from its condition to approval section.
B. THE PROVISIONS OF RENEWAL HAVE BEEN INCORPORATED IN FORM 24C I.E., 'HOMOEOPATHIC MEDICINES'-
Form 24C i.e., "Application for the grant or renewal of a license to manufacture for sale or for distribution of Homoeopathic medicines or a license to manufacture potentized preparations from back potencies by licensees holding license in Form 20C"
C. THE INSERTION OF RULE 77 AND RULE 82 TO ADD MORE CLARIFICATION REGARDING 'DURATION OF LICENSES':
"77. Duration of license- A license issued in Form 28 [Schedules C and C (1)excluding X], Form 28B [Schedules C, C(I) and X] and Form 28D [Large Volume Parenterals/Sera and Vaccines/recombinant DNA (r-DNA) derived drugs Schedules C, C(I) and X] shall remain valid, if the licensee deposits a license retention fee before the expiry of period of every succeeding five years from the date of its issue, unless it is suspended or cancelled by the licensing authority.
If case of non-payment of license retention fee on or before the due date, the licensee shall be allowed to pay license retention fee along with a late fee (2% of retention fee every month) for the next 6 months, and in case of non-payment of such fee, the license shall be deemed to have been cancelled.
" 83. Duration of loan license- A loan license issued in Form 28 [Schedules C and C (1)excluding X], Form 28B [Schedules C, C(I) and X] and Form 28D [Large Volume Parenterals/Sera and Vaccines/recombinant DNA (r-DNA) derived drugs Schedules C, C(I) and X] shall remain valid, if the licensee deposits a license retention fee before the expiry of period of every succeeding five years from the date of its issue, unless it is suspended or cancelled by the licensing authority.
If case of non-payment of license retention fee on or before the due date, the licensee shall be allowed to pay license retention fee along with a late fee (2% of retention fee every month) for the next 6 months, and in case of non-payment of such fee, the license shall be deemed to have been cancelled."
Conclusion
The amendment would ensure the smooth processing of applications for grant of manufacturing licenses and promote ease of doing business for drug manufacture and drug distributors.
Footnotes
2. http://www.egazette.nic.in/WriteReadData/2019/207196.pdf
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