Non-Covid drugs and vaccines likely to get fast-track approval too

The domestic pharma industry has urged the Central Drugs Standards Control Organisation (CDSCO) to consider extending the fast-track approval process adopted during Covid-19 for vaccines and even drugs that were re-purposed for treating Covid-19 patients, to non-Covid drugs as well.

Multiple industry sources confirmed the development. The head of a pharma lobby group told Business Standard, “During Covid19, the CDSCO had adopted a fast-track and rolling review system for approving essential drugs and vaccines that were needed urgently for treating patients. Drugs such as remdesivir or favipiravir, etc, are a case in point. The industry has requested that such best practices be now formally extended to the non-Covid-19 drug approval process too.”

He added that the system of drug approvals typically takes several months. “India is primarily a generics market, and, thus, typically companies take approval for drugs through the bio-equivalence route. However, now with enhanced focus on innovation, it becomes necessary to streamline our approval process and make them target-linked,” said the official quoted above. Bioequivalence is the biochemical similarity of two (or more) drugs that share the same active ingredient(s) and desired outcome(s) for patients.

A senior CDSCO official confirmed that there are plans to adopt the best practices used during the Covid-19 pandemic for non-Covid19 drugs too. “We have made detailed notes of the processes adopted during the pandemic to approve drugs and vaccines in a fast-track manner. This was done without compromising on safety or efficacy. Just that the review process was a continuous one,” he said, adding that now the idea is to do the same for all drugs and vaccines that seek approval from the CDSCO.

“The process of rolling reviews, for example, where the drug manufacturer has shared data with the CDSCO at each step of the clinical trials, or bioequivalence studies, etc, is a very useful tool. Similarly, the CDSCO teams and experts have handheld the pharma firms on what kind of data needs to be generated, and what are the specific requirements for approval. These processes can be extended for non-Covid drugs too,” he said.

“The old process of leisurely looking at the data multiple times, looking at the complete data set before we move on to the next step sequentially was changed,” a CDSCO official said.