India: Drugs And Cosmetics (Tenth Amendment) Rules, 2017

"The licenses once issued, shall remain valid forever, unless suspended or cancelled by the licensing authority"

On October 27, 2017, the Ministry of Health and Family Welfare has published the Drugs and Cosmetics (Tenth Amendment) Rules, 2017 through official gazette, in exercise of the powers conferred by section 12 read with section 33 of the Drugs and Cosmetics (D&C) Act, 1940 (23 of 1940); further after consultation with the Drugs Technical Advisory Board has proposed the following rules to amend the Drugs and Cosmetics Rules, 1945, namely:-

Duration of licence

1. As per the amendment a various licenses once issued under Form 20, 20A, 20B, 20BB, 20F, 20G, 21, 21A, 21B, 21BB, Form 25, Form 25B, Form 25F, Form 32, Form 32A, Form 33 and Form 37; whereas loan license also issued in Form 25A shall remain valid, if licensee deposits a license retention fee referred to in sub-rule (2) before the expiry of a period of every succeeding five years from the date of its issue, unless, it is suspended or cancelled by the licensing authority.

2. The license retention fee referred to in sub-rule (1), shall be equivalent to the respective fee required for the grant of such license excluding inspection fee paid for grant of license.

3. If the license holder fails to pay license retention fee on or before the due date as referred to in sub-rule (1), he shall be liable to pay license retention fee along with a late fee calculated at the rate of two per cent of the license fee for every month or part thereof up to six months, and in the event of non-payment of such fee, the license shall be deemed to have been cancelled.

Inspection for grant of license and verification of compliance

1. Before grant of manufacturing license under Form 25, Form 25A, Form 25B, Form 25F, Form 28, Form 28A, Form 28B, Form 28D, Form 28DA, Form 32, Form 32A and Form 33, the licensing authority shall cause the es- tablishment in which the manufacture of drugs is proposed to be conducted or being used, to be inspected jointly by the Drugs Inspectors appointed by the Central Government and the State Government under this Act who shall examine the establishment intended to be used or being used for the manufacture of drugs.

2. The premises licensed under sub-rule (1) shall be jointly inspected by Inspectors appointed by the Central Government and the State Government to verify compliance with the conditions of license, the provisions of the Act and these rules, not less than once in three years or as needed as per risk based approach."

Inspection for verification of compliance

The licensing authority shall cause inspection, by the Inspector appointed under the Act, of each premise licensed under this Part, to verify the compliance with the conditions of license and the provisions of the Act and these rules, not less than once in three years or as needed as per risk based approach.

Apart from this, a paragraph in Schedule A regarding various forms has been amended as follows:

"The license, unless sooner suspended or cancelled, shall remain valid perpetually. However, the compliance with the conditions of license and the provisions of the Drugs and Cosmetics Act, 1940 (23 of 1940) and the Drugs and  Cosmetics Rules, 1945 shall be assessed not less than once in three years or as needed as per risk based approach." Moreover, the word "Renew or Renewal or Renewed" shall be omitted from various forms of Schedule A"⁹.

Note - The Drugs and Cosmetics (Tenth Amendment) Rules, 2017 is effective from March 27, 2017. However, the CDSCO has published following interim guidelines to ensure the smooth processing of applications for grant of manufacturing licenses; and for joint inspection of manufacturing premises –

1. Application for the grant of manufacturing licenses, complete in all respect as per the provisions of Drug and Cosmetic Act, 1940 and Rules, 1945 should be submitted by manufacturer to the respective State Licensing Authority.

2. The State Licensing Authority should fix a date at least seven days prior to the date of joint inspection of the manufacturing premises, in coordination with the respective zonal/ Sub-zonal offices of CDSCO.

3. In case drug inspector of CDSCO zonal/sub-zonal offices is not available on any specific date, drug inspector from CDSCO (HQ) will be deputed for the joint inspection.

4. Proper coordination between State Licensing Authorities, CDSCO HQ and Zonal/ Sub-zonal offices should be ensured for timely inspection and processing of applications.

5. In case of deficiency in the application in respect of any inspection, the joint inspection team may verify such document during the inspection and record detail of the same in the inspection report¹⁰.

However, valuable feedback or suggestions for these guidelines will be also appreciated by CDSCO for further improvement in the implementation of the new rules.

Footnotes

9 http://www.cdsco.nic.in/writereaddata/GSR%201337(E)%20dated%9 http://www.cdsco.nic.in/writereaddata/GSR%201337(E)%20dated% 2027_10_2017.pdf

10 http://www.cdsco.nic.in/writereaddata/library%2024.11.17.pdf

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