NEW DELHI: The central drug regulator has removed a key hurdle for the domestic generic drug launches by exempting nearly half of all low-risk bioequivalence (BE) studies from prior approval. The move has eliminated around 3,000 No Objection Certificates (NOCs) annually, based on the current spate of applications from drugmakers.
BE studies are critical to develop generic drugs as they establish that a generic drug have same effect as the innovator drug. They are a mandatory step in generics development. At the FE Healthcare Summit & Awards 2026 here on Friday, the Drugs Controller General of India Rajeev Raghuvanshi said that by replacing the approval regime with a simple intimation process, the regulator has the shortened the drug development timelines, reduced uncertainty for pharma companies and contract research organisations (CROs), and freed up regulatory resources for crucial oversight activities.
“There was no value addition by the regulator in many of these permissions. So, we have freed almost 50% of these bioequivalence studies from prior approval. It helps the industry and also frees our resources to do much more value-added work,” Raghuvanshi said.
Besides bioequivalence studies, companies carrying out R&D and pre-clinical drug development no longer require prior approval from Central Drugs Standard Control Organisation (CDSCO) and only need to notify the regulator before commencing research. According to Raghuvanshi, the changes are intended to reduce what he described as “regulatory anxiety” among innovators while maintaining oversight where it matters. “We are trying to solve the problem of regulatory anxiety. Till the companies go for first human testing, they don’t need to come to the regulator,” he said.
The regulator said that it has digitised 99% of its processes and is developing an integrated end-to-end digital platform linking the different components of value chain – such as CDSCO, state drugs regulators, manufacturers and retailers – with the first phase of the project expected to become operational within the next 18 months.
Raghuvanshi also rejected the perception that regulation hampers innovation. He argued that a credible regulatory framework is essential for domestically-produced medicines to compete globally. “It looks like a roadblock, but it is essential for our international acceptability. Products coming through a robust regulatory system have easier access to the international markets,” the regulator said.
Even as CDSCO has reduced the compliance burden on drugmakers, it is tightening post-market surveillance at the same time. The regulator now publishes around 200 ‘Not of Standard Quality’ (NSQ) drug alerts every month and issues Corrective and Preventive Action (CAPA) notices to manufacturers whose products fail quality tests. Companies are required to identify the root cause of the quality failure and implement corrective measures before regulatory restrictions are lifted.
“Every company whose product is declared NSQ receives a CAPA notice. They have to identify the problem, correct it, and satisfy the regulator before the suspension is removed. Over time, products will either improve and comply with quality standards or exit the market altogether,” Raghuvanshi said.
To strengthen the drug regulatory system, the government has given an in-principle approval for the creation of 1,500 additional posts in CDSCO. As per Raghuvanshi, the new cadre will include engineers, doctors, protocol designers, toxicologists, bio-statisticians and other scientific specialists that will enable the regulator to build a strong in-house expertise and reduce its dependence on external Subject Expert Committees (SEC).
The CDSCO has simultaenously begun inducting professionals with hands-on drug development experience from the industry into these committees to improve the quality of scientific evaluation of new drug applications.
“For years, we have depended almost entirely on external experts. They have made a significant contribution, but we are now expanding the committees to make sure that at least one member in these committees has a hands-on experience in drug development. The quality of discussions and decision-making has already improved,” he said.
Source: The Financial Express
