EXEMPTION FOR DRUGS ALREADY APPROVED IN DEVELOPED MARKETS Pharma Inc Divided over Plan to Waive Off Select Clinical Trials

Some say tests in India necessary, others claim move to help drug availability
The government’s decision to waive off mandatory local clinical trials for certain drugs that are already approved by regulatory authorities in places including the UK, US, and EU have evoked mixed reactions from the industry, with many experts saying it is essential to conduct trials in the country to guarantee a drug’s safety and efficacy in the Indian population. India’s diverse population has
unique genetic profiles, which can affect drug metabolism, efficacy, and safety, they told ET, citing the genetic and ethnic diversity of the Indian population. Some also believe that this will speed up availability of drugs in India, especially the new drugs. “Launching a new drug in India takes up to four years compared to the developed markets. This affects the care of treatment for the patients here. With this provision now, things will ease and new drugs will get introduced without any delay,” said an expert.
In a move aimed at speeding up the availability of new drugs and medical devices in the country, the government has done away with the requirement of clinical investigation of those new drugs having significant therapeutic advance over the current standard care and has already got approval in the US, UK, Japan, Australia, Canada and the EU.
Clinical trial waiver will also be considered for drugs for rare diseases, gene and cellular therapy pro ducts, new drugs used in pandemic situations, and new drugs used for special defence purposes that are approved in these places.
“While waiving trials for new drugs approved in developed nations might seem efficient, the requirement for clinical trials in all Indian geographies (North, South, East, and West) ensures that the drug’s performance is evaluated in various ethnic and genetic subgroups,” said an expert who requested not to be identified.
Rajiv Nath, forum coordinator at Association of Indian Medical De vices Industry (AiMeD), said that under exceptional circumstances, clinical trials of medicine or clinical investigation of medical devices can be fast-tracked on mutual recognition agreement under bilateral trade negotiations with the EU or certain countries, but to give a complete waiver is not recommended due to safety concerns. “All that’s made in the West may not be unquestionably ok,” he said. Public health experts said different genetic polymorphisms, variations in diet and lifestyle, prevalence of specific diseases or conditions, and exposure to environ- mental factors make it all the more important for country-specific clinical trials.
“Conducting trials across India’s diverse regions helps to identify potential safety concerns or efficacy variations, ensures the drug’s effectiveness in the target population, and enhances patient safety and outcomes,” the expert cited above said.
Source: Economic Times