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CDSCO to consider waiving off clinical trials for orphan drugs

While currently there is no definition on orphan drugs in India, medicines that are used in treatment rare diseases, with less than five lakh patients, typically fall under this category.

February 26, 2019 / 02:21 PM IST

Companies developing orphan drugs will soon get a boost from Indian drug regulator through partial and full waiver of clinical trials depending on specific drugs, said Chandrashekar Ranga, Deputy Director General of Central Drugs Standard Control Organization (CDSCO).

The government is expected to come out with a clear policy on approvals of orphan drugs in the New Drugs and Clinical trials Rules, 2018, which will be notified in coming weeks.

"It is in advanced stage," Ranga said on the sidelines of BioAsia 2019 in Hyderabad.

While currently there is no definition on orphan drugs in India, medicines that are used in treatment of rare diseases with less than five lakh patients typically fall under this category.

Most often, orphan drugs are priced beyond the reach of most patients.


There is a huge unmet need for drugs to treat orphan diseases but due to low number of patients and costs associated with clinical trials, most companies keep away from development of orphan drugs, Ranga said.

"There will be abridged pathway to approve orphan drugs, that reduces the cost and time for the drug to reach market at affordable cost," he said.

Ranga also said for new drugs which are already approved in highly regulated markets such US and Europe, CDSCO will consider waiver of clinical trials in India.

CDSCO will also be reducing the time taken for approval of clinical trials to 45 days for domestic companies and 90 days for overseas companies from the existing 120 days and above.
Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
first published: Feb 26, 2019 02:16 pm

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