With more and more drug makers scouting for manufacturing hubs in foreign lands, the government has decided to ease clinical trial procedures in India. The apex body to control clinical trials and drug quality issues, the Drug Controller General of India (DCGI), has amended some critical clauses.
The government, as per the draft issued on August 4, has taken several measures such as removal of restrictions on the number of trials to be conducted at a given point of time. Due to the increasing number of deaths during trials, the government had earlier imposed a restriction of not more than three clinical trials to be conducted by an investigator. Restrictions on number of minimum beds at the clinical trial site have also been removed. Earlier, the clinical trial site was mandated to have at least 50 beds.
The drug makers also now do not need to take ‘no objection certificate’ from the DCGI in case of addition or deletion of new clinical trial site or investigator.
HT on August 1 reported that in a move against Prime Minister Narendra Modi’s much-hyped ‘Make in India’ initiative, domestic drug makers are hunting for manufacturing hubs on foreign lands citing many reasons, including bottlenecks in the clinical trial process.
“The idea is to create conducive environment for the pharma sector to enter swiftly into drug discovery and research phase,” said GN Singh, DCGI.
Citing data from Dealogic, Dow Jones Business News reported that Indian drug makers in 2015 struck deals worth $1.5 billion for manufacturing operations based in the US.
According to the Central Drugs Standard Control Organisation (CDSCO), around 65 trials were approved in 2008, whereas it jumped to 391 in 2009, and 500 in 2010. However, following the Supreme Court’s intervention, the approvals dropped drastically from 2011 onwards.
Domestic pharmaceutical firms, including Biocon, Lupin and Glenmark, have invested in manufacturing units based in foreign countries.
For Instance: Bangalore-based biotech major Biocon has set up Asia’s largest integrated insulins manufacturing facility at an investment of over $250 million, which is the highest foreign investment in Malaysia’s biotech sector till date. Also, Lupin operates 18 manufacturing facilities across Japan, USA, Brazil and Mexico.
“There are several reasons why a pharmaceutical company would invest in manufacturing facilities outside of India. For instance, it makes sense to have local manufacturing operations in a market like Brazil for the ease of getting approvals...,” said Ramesh Swaminathan, chief financial officer, Lupin Ltd.