Responding to pharmaceutical industry's appeal for doing away with repeated joint inspections of manufacturing plants offering loan licenses, the Central Drugs Standard Control Organization (CDSCO) has decided not to conduct joint inspection of loan licenses of same plants in Maharashtra which were jointly inspected by the Centre and state drug inspectors for grant of licenses.

The decision to this effect was taken by CDSCO, West Zone following an appeal by industry body Indian Drug Manufacturers Association (IDMA) as well as Maharashtra Food and Drug Administration.

The industry body in a meeting with state FDA commissioner had raised the issue of repeated joint inspections of manufacturing premises for grant of loan license causing undue hardship to pharmaceutical firms.

The joint inspection of the loan licenses of the same plants will not serve any purpose and may only delay the licensing process. It may affect competitive advantage of drug units seeking to manufacture products at loan premises, it said.

Maharashtra FDA Commissioner discussed the issue with B N Prasad, Deputy Drugs Controller, CDSCO West Zone during the meeting on February 28, 2018 in the FDA, Maharashtra.

There are 3,000 drug manufacturing units in Maharashtra.

CDSCO West Zone in a letter to state FDA commissioner stated that wherever joint inspection of the manufacturing premises have been carried out for grant of license as per GSR 1337(E) dated 27/10/2017, further joint inspection of the loan licenses of the same premises may not be necessary, so as to avoid delay.

However, further joint inspection will be carried out as per rules periodically and based on risk based approach.

Ministry of Health and Family Welfare, Government of India has amended the Drugs and Cosmetics Rules, 1945 vide Notification No. G.S.R.1337 (E) dated 27.10.2017 providing that manufacturing licence for drugs and cosmetics and approval of drugs/cosmetics testing laboratories shall remain valid if the licencee deposits licence retention fee before the expiry of period of every succeeding five years from the date of issue, unless, it is suspended or cancelled by the licensing authority.

The amendment also provides that before grant of licence in Form 25 or Form 25A or Form 258 or Form 25F or Form 28 or Form 28A or Form 28B or Form 280 or Form 28OA to manufacture for sale or for distribution of Drugs or in Form 32 or Form 32A or Form 33 for manufacture of cosmetics, the state licensing authority shall cause the manufacturing premises to be inspected jointly by the central and state drugs inspectors. Further, the premises licensed shall be inspected jointly to verify the compliance with the conditions of licence and the provisions of the Act and the Rules not less than once in three years or as needed as per risk based approach.