DCGI Waives Compulsory Clinical Trials of Each Vaccine Batch

NEW DELHI, June 2: To ease the supply of imported COVID vaccines, the Drug Controller General of India (DCGI) has waived the requirement of conducting bridging clinical trials and testing of every batch of vaccine by the Central Drugs Laboratory (CDL), Kasauli for foreign-made vaccines.

The DCGI said it has been decided that for approval for restricted use in emergency situations which are already approved for restricted use by the U.S. Food and Drug Administration, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, U.K., Pharmaceuticals and Medical Devices Agency, Japan, or which are listed in WHO Emergency Use Listing and which are well established vaccines from the standpoint that millions of individuals have already been vaccinated with them, the requirement of conducting post approval bridging clinical trials and of testing every batch of vaccine by CDL, Kasauli can be exempted, if the batch/lot has been certified and released by the National Control Laboratory of the country of origin.

The decision comes at a time when Pfizer and Cipla are negotiating deals with the Indian government for supplying vaccine. Pfizer has told the Centre it wants relaxation on the requirement for a post-approval bridging trial for its vaccine, developed with BioNTech, and testing of these vaccines at CDL Kasauli. Cipla, which has been looking to commit $1 billion into bringing Moderna’s single-dose mRNA booster vaccine to India, has also requested an exemption from bridging trials.

The DCGI in its one-page notice said scrutiny of the summary lot protocol and certificate of analysis of batch or lot shall be undertaken by the CDL for release as per standard procedures and requirement of assessment on the first 100 beneficiaries for seven days for safety outcomes before the vaccine is rolled out for further immunisation programme.

The Health Ministry on Wednesday said with the aim of vaccinating the entire eligible population at the earliest, domestic production is being steadily ramped up with help from the Centre.

“As part of this initiative, three public enterprises are being supported by the Department of Biotechnology under Atmanirbhar Bharat 3.0 Mission Covid Suraksha. These enterprises are Haffkine Biopharmaceutical Corporation Ltd, Mumbai, Indian Immunologicals Ltd, Hyderabad and Bharat Immunologicals & Biologicals Ltd, U.P. Haffkine Biopharma is getting ready to manufacture Covaxin under technology transfer arrangement with Bharat Biotech Ltd, Hyderabad. The production will take place at the Parel complex of the company,’’ said the release.

Sandeep Rathod, MD of Haffkine BioPharma, said the company proposes to produce 22.8 crore doses of Covaxin in a year. “For undertaking production of Covaxin, Haffkine Biopharma has been provided with ₹65 crore grant by the Centre and ₹94 crore from the government of Maharashtra,” he said.

“We have been given a timeline of eight months and the work is being executed on a war footing. The vaccine production process involves two stages — drug substance and final drug product. For production of drug substances we need to build a Bio Safety Level 3 (BSL 3) facility, while Haffkine already has the Fill Finish facility,” said Dr. Rathod. BSL 3 is a safety standard applicable to such facilities where work involves microbes which can cause serious disease via inhalation route.

“Enhancing production capacity using public sector assets will go a long way in building production capacity to support the massive vaccination drive,” said Renu Swarup, Secretary Department of Biotechnology and Chairperson BIRAC (Biotechnology Industry Research Assistance Council).

The latest DCGI exemptions modify an earlier notice by it on April 15 that allowed foreign companies with approvals from the same regulatory authorities as mentioned in Wednesday’s order to skip the requirement for local clinical trials in their request for Emergency Use Authorization.

The latest decision was taken “as per (the) recommendation of NEGVAC (the National Expert Group on Vaccine Administration for Covid-19),” according to the notice.

(Manas Dasgupta)