Express Pharma

Govt extends validity of import licence & registration certificate by six months

The move is to ensure the availability of medicines in the country

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With an aim to ensure the availability of medicines amidst the prevailing corona virus in the country, the government has given an extension of six months for the validity of import licence (Form-10).

The move is in response to a request from the pharmaceutical companies and their associations seeking extension of the validity of import licence (Form-10) for six months in the wake of COVID-19 pandemic.

The gazette notification by the Ministry of Health and Family Welfare (MoHFW) dated November 26, 2020 stated that several import licences in Form-10 are in existence and their validity periods of three years are likely to expire shortly; whereas, pharma companies and their associations have requested for extension of the validity of import licence (Form-10) for six months in the wake of COVID-19 pandemic.

Considering this, the Central Government is in view of that supply of drugs may not get affected and the drugs must remain available to the public. Therefore, in exercise of the powers conferred by section 26B of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, directed that notwithstanding anything contained in rule 28 of the Drugs and Cosmetics Rules, 1945, for import of drugs for sale or distribution, if an existing valid import licence holder under the said rules, makes an application for a fresh import licence before the expiry of the existing licence, the existing import licence shall be valid until orders are passed on the application and shall be deemed to be valid for all purposes.”

Dr Viranchi Shah, National Vice President, IDMA expressed, “It is a welcome step by the Ministry. It will help maintain the uninterrupted inventory of imported materials, helping the formulations industry to work smoothly.”

The order will be valid for a period of six months from the date of its publication in the Official Gazette.

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