As Regulatory Problems Accumulate In India, Clinical Trials Sector Looks to Flee

Posted 14 June 2012 | By Alexander Gaffney, RAC 

Can regulatory oversight simultaneously be both too much and not enough? Such is the case of India, reports The Economic Times, whose regulated industry is protesting both its increasingly strict clinical trial regulations and the dearth of regulatory oversight practiced by the Central Drugs Standard Control Organization (CDSCO).

The combination of factors is causing some manufacturers to reexamine their operations in the country, and whether it makes sense to move to other countries in South-east Asia, reports The Times.

The country has been embroiled with problems-real or perceived-with its clinical trials sector in recent years, with various entities castigating the sector and government for misconduct, low capacity to regulate clinical trials, lax oversight, compliance concerns, ethical concerns, and a lack of compensation for trial participants.

The result of all this has been a slowdown in the clinical trials sector starting in 2010 thanks to what BioSpectrum Asia called a "vague regulatory structure." While authorities have promised to cut approval times, their ability to do so may be hampered by the ongoing investigations into the ability of the CDSCO to regulate the sector effectively, which may lead to more-not fewer-regulatory hurdles for the industry.

A cost-conscious sector may ultimately choose to pick up and leave entirely, reports The Times, particularly given the cavalcade of regulatory hiccups in the country and the potential for cost savings elsewhere in Asia. Others simply want a regulatory authority that is more responsive to the needs of the sector.  "There is complete paralysis of regulation, and we cannot have policy that takes us backwards, a good industry needs a good regulation," Swati Piramal, director of Piramal Healthcare Limited, told The Times. "The regulators should understand that."


Read more:

The Economic Times of India - Hit by red tape, clinical trial companies eye South-East Asia for expansion


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