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Foreign COVID-19 vaccine makers exempted from local clinical trials, batch testing

Foreign COVID-19 vaccine makers exempted from local clinical trials, batch testing

DCGI said the requirement of conducting post approval bridging clinical trials and requirement of testing of every batch of vaccine by the CDL can be exempted, if the vaccine lot/batch is certified and released by National Control Laboratory of country of origin

DCGI relaxes rules for foreign COVID-19 vaccines DCGI relaxes rules for foreign COVID-19 vaccines

The Drug Controller General of India (DCGI) has further relaxed rules for importing COVID-19 vaccines, by exempting rules like mandatory bridging clinical trials and testing of each batch of imported vaccines at India's Central Drug Laboratory (CDL) at Kasauli in Himachal Pradesh.

In an order issued on Tuesday, the DCGI said the requirement of conducting post approval bridging clinical trials and requirement of testing of every batch of vaccine by the CDL can be exempted, if the vaccine lot/batch is certified and released by National Control Laboratory of country of origin.

This will help global COVID-19 vaccine makers like Pfizer, Moderna and other companies developing vaccines to sell their vaccines in India at almost the same time as they launch it in overseas countries.

The earlier rules for new drugs and vaccines had stipulated that those products which had completed Phase 3 vaccine studies outside the country should undergo 'bridging trials' or limited clinical trials on Indian population to know how the drug works on people of Indian origin. Since the country is facing severe shortage of COVID-19 vaccines, this clause was seen as a major impediment and a delaying factor in bringing overseas COVID-19 vaccines into India. On April 15, as per the recommendation of the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC), the DCGI had relaxed the rules. By this, the drug regulator allowed COVID-19 vaccines which are already approved for restricted use by regulatory agencies of US FDA, EMA (Europe), UK MHRA, PMDA of Japan or which are listed in WHO Emergency Use Listing (EUL) and 'which are well established vaccines from the standpoint that millions of people have been vaccinated with the said vaccines'.

India has so far allowed only three vaccines - indigenously developed Covaxin, Serum Institute's Covishield and Russia's Sputnik V vaccine. Dr Reddy's, the marketing partner for the Russian vaccine, had to undertake local trials that lasted a few months, before getting its approval. Also, each batch of these vaccines have to be tested and approved before distribution at the Central Lab in Kasauli.

"However, scrutiny and review of their summary lot protocol and certificate of analysis of lot/batch shall be undertaken by CDL Kasauli for batch release as per the standard procedures and the requirement of assessment on the first 100 beneficiaries for 7 days for safety outcomes before the vaccine is rolled out for further immunisation programme, along with other procedures for filing of other applications and timelines for processing of the applications etc," said Dr VG Somani, DCGI, in his order.

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