Ramesh ShankarWednesday, June 13, 2018, 08:00 Hrs  [IST]

A section of the pharmaceutical manufacturers and state drug control officials are opposing the Drugs Controller General of India's decision to conduct joint inspections of facilities by the Central and state drug inspectors before granting a licence to a drug or cosmetic manufacturing unit. So far, such inspections used to be carried out by state drug inspectors alone. For this purpose, the Union Health Ministry had amended the Drugs & Cosmetics Rules, 1945 and had issued a notification dated 27.10.2017.  The notification mandates that the Central Drugs Standard Control Organisation shall jointly inspect pharmaceutical units with state drug inspectors so as to check compliance of GMP. Licenses to new units shall also be subject to joint inspections prior to grant of licence and risk-based inspections shall be carried out in units whose samples fails quality tests. 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. The Health Ministry's decision to conduct joint inspection is aimed at streamlining uniform inspection procedures across the country related to implementation of GMP. The organisations for drug control exist at central and state levels in the country. Until now, the Central Drugs Standard Control Organisation handles licensing work such as approvals meant for manufacture of large volume parenterals, vaccines and sera, blood banks and blood components, medical devices and products manufactured by recombinant technology. It also deals with new drug clearance, clinical trials, import registration and inspections. On the other hand, the state drug control department deals with licensing of both manufacturing and sales premises of drugs and cosmetics.

Now, there are fears among the industry that the joint inspection could slow down the licensing process for manufacturing units as a section of the industry is concerned about the CDSCO’s lack of manpower to conduct timely joint inspections along with their state counterparts. The industry's apprehension is that since the central drug authority doesn’t have enough staff for this purpose, the state officials will be waiting for the central authorities’ participation in every inspection and it may result in licensing process getting delayed. Annoyed over the ministry's decision, the Punjab Drug Manufacturers Association has recently filed a Writ Petition in the Punjab High Court in which it has stated this 'illegality' has created an Inspector Raj and it is a burden which industry does not afford especially in view of levy of a stringent GST regime. Besides the industry, the state drug control officials are also opposing the ministry's decision as they see it as an intrusion into state governments’ powers.  All India Drugs Control Officers Confederation, an association of drug control officers of state governments, has also moved court against the government. It is true that in certain northern states where state drug officials do not have the expertise to conduct proper inspections, this step will help improve quality of drugs in the country. But, since there is widespread apprehension among the industry as well as the state drug control officials, the ministry should take some urgent measures to take them into confidence and allay their fears.