Govt gives validity extension of six months on registration certificate to pharma companies

Companies need to apply for a fresh registration certificate before the expiry of the existing certificate

The Department of Health and Family Welfare, under the Ministry of Health and Family Welfare (MoHFW), has issued a notification extending the validity of registration certificate for six months due to the pandemic crisis with an aim to ensure the uninterrupted supply of medicines in the country. This move will allow companies to import the required active pharmaceutical ingredients (APIs) and other required materials without delays related due to the registration certificate. However, to continue import activities, companies need to apply for a fresh registration certificate before the expiry of the existing certificate.

According to the issued notification, the department has mentioned that in the wake of COVID-19 pandemic, it received several requests from pharma companies and their associations for an extension of the validity of registration certificate under Form-41 for six months. The Central Government is of the considered view that the supply of drugs may not get affected and the drugs must remain available to the public.

Therefore the notification states, “In exercise of the powers conferred by section 26B of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government directs that notwithstanding anything contained in rule 28A of the Drugs and Cosmetics Rules, 1945, for import of drugs for sale or distribution, if an existing registration Certificate holder under the said rules, makes an application for a fresh registration certificate before the expiry of the existing certificate, the existing registration certificate shall be valid until orders are passed on the application and shall be deemed to be valid for all purposes.”

Sunil Attavar, President, Karnataka Drugs and Pharmaceuticals Manufacturers Association (KDPMA) commented, “It is a balanced move to extend import registration for a limited period of six months to those who apply for renewal before the expiry of the existing approval. It will ensure that there is no shortage of active pharmaceutical ingredients (APIs) in these difficult times.”

BR Sikri, Chairman, FOPE and Vice President, BDMA highlighted, “It is a timely and positive decision taken by the Government so that there is no shortage of any particular drug in the country. These timely, constructive and positive decisions are always giving a breather to the industry. We acknowledge this timely gesture by the Government of India and hope that the industry and government will join hands to overcome such problems so that end-users or patients do not suffer due to unavailability of essential medicines. We also acknowledge many such positive decisions taken by the CDSCO during the COVID-19 pandemic wherein flexibility and positivity are indicative of the Government’s intention. It is incumbent upon all of us to think about the nation first.”

Dr Viranchi Shah, National Vice President, IDMA, said, “It’s a welcome step and it will allow the uninterrupted supply of imported drugs and APIs, where registrations could not be renewed due to current disruption.”

Dinesh Dua, Chairman, Pharmexcil and Director, Nectar Lifesciences commented, “It is a good step in the right direction as the onus is on authorities to renew or else it’s deemed extended till renewal. Not only does it give relief to industry but also to regulators who are deeply stressed on account of COVID-19 implications and associated stress levels.”

active pharmaceutical ingredientsBDMABR SikriFOPEgovernment notificationIDMAKDPMAMoHFWpharma importsregistration certificateSunil AttavarViranchi Shah
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  • Dr Appaji

    I think six months period is not mentioned , madam!