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Validity Of Import License And Registration Certificate For Drugs Extended For Six Months Due To The Covid Pandemic Situation.

Government has extended the validity of the import license along with the registration certificate by six months. This step has been taken to make sure the medicines are available in the country. On July 27 2020, the Ministry of Health and Family Welfare gave a notification affirming that drug supply should not be affected and it should remain accessible to the public. So, due to the ongoing pandemic, COVID-19 pharmaceutical companies have wished for extending the validity of the registration certificates for about six months. Thus, exercising the powers deliberated by section 26B under Drugs and Cosmetics Act, 1940, the central government directed a notice, without withstanding anything in the rule 28A of the Drugs and Cosmetics Rules, 1945 for drugs import for the sole purpose of sale or distribution. That if an existing registration certificate holder as per given rules applies for a fresh registration certificate before expiry of the present, the present certificate will remain v
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The Requirement Of Cmc Documents For Approval Of Additional Manufacturing Facility For An Already Approved Drug Product.

  The Drugs Controller General of India or DCGI has approved to manufacture new drugs in an additional facility of a manufacturer but on a condition. The manufacturer has to establish similarity through technology transfer in respect to the manufacturing process. In addition to technology transfer, conditions also involve equipment, process capability, bridging validation as well as process parameters. This all is required for transfers between proposed additional manufacturing sites and the site that has been already approved. It has been quite a time now when such requirements for the manufacturing of any novel drug in an additional site of a manufacturer has been under discussion. Thus, in a circular DCGI stated to all stakeholders that all manufacturers should obtain license or permission from the required authority for generating chemistry, manufacturing and control or CMC documents. Based on the given CMC documents by the manufacturer, approval or permission will be granted for
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