In a significant move, the Central Drugs Standard Control Organisation (CDSCO) has decided to relax rules including a possible waiver of clinical trials for orphan drugs used in the treatment of rare diseases. Proposed as part of the New Drugs and Clinical Trials Rules-2018, expected to be notified in March, the CDSCO intends to provide a pathway so that even with limited data, orphan drugs can be approved, with or without a trial. In other words, a partial or full waiver of clinical trials is in the offing for specific drugs, provided such tests are conducted elsewhere, particularly in advanced nations like the US or Europe. As per Indian norms, any drug, old or new, has to conduct clinical trials before proceeding with the commercial launch. “The reason is that the number of patients (with rare diseases) may be 500-1000 (in India) and with such low numbers, it’ll be difficult for them (clinical trials) to be economically viable. The new rules give regulatory freedom to launch (orphan drugs),” said Chandrashekar Ranga, deputy director-general, CDSCO. Orphan drugs are medicines used in the treatment of rare diseases with less than five lakh patients in a country, but are believed to be expensive.
Speaking to media on the sidelines of BioAsia 2019, Ranga said the matter of approvals will now be given in a few weeks. Currently, as per the notification, there are no regulatory pathways for approval of orphan drugs. The upcoming rules will offer a constant pathway for approvals and reduce the cost and time to market the drug at affordable prices. According to him, the Indian drugs regulator is also considering waiving off Indian clinical trials of such medicines that are already applied in advanced economies like the US and Europe. The incoming rules on clinical trials are expected to reduce the time taken for approval of clinical trials to 45 days for domestic companies and 90 days for foreign companies from the current 120 days. However, pharma companies often complain that seldom was this deadline adhered to, causing severe delays in approvals. From next month, when the rules are notified, companies can proceed with the trials after 45 and 90 days even if they do not get the regulatory nod. Meanwhile, dismissing reports about the falling number of clinical trials in the country, Ranga said that in reality, trials have been on the rise over the past two to three years.
Boost to drug market
The upcoming rules on clinical trials will offer a constant pathway for approvals and reduce the cost and time to market the drug at affordable prices. The new rules are expected to reduce the time taken for approval of clinical trials to 45 days for domestic companies and 90 days for foreign companies from the current 120 days. – New Indian Express