Updated on 17 August 2012
India is plagued with problems in drug approvals
India received a lot of criticism in the past few months after a report exposed malpractices in the functioning of Central Drugs Standards Control Organization (CDSCO). The report by the parliamentary standing committee on health and family welfare has come down heavily on the CDSCO for the discrepancies. However, there are other issues that need to be addressed in order to plug the gaps.
Where are all the regulators?
It is very easy to play the blame-game without getting to the crux of the issue as the lack of efficient manpower is a major concern in the regulatory scenario of the country. No action has been taken after the Mashelkar report was published describing the required infrastructure at the CDSCO.
Dr Krathish Bopanna, president, ISCR, and president and executive director, Semler Research Center said, "There do exist competent people capable of executing necessary decisions but they suffer from the lack of sufficient manpower and high workload. The CDSCO is very strong in terms of pharmaceutical manufacturing but is still ill-equipped to deal with the clinical and marketing aspects of drugs."
At the CDSCO, less-than-half of the 327 sanctioned posts, at the time of the report being released, were filled up. Also in terms of drug inspectors, there are only 846 instead of the required 1,349. More shockingly, the minimum prescribed academic qualifications for the post of DCGI is barely a Bachelor of Pharmacy (B.Pharm) degree, which well below the global standards. The 59th report of the parliamentary standing committee on the functioning of the CDSCO raises many such questions on the functioning and the decisions of the CDSCO.
There is a apprehension among MNCs that is preventing them from investing in trials in India. They fear that the lack of data protection will help generic companies to use their data in future. This concern needs to be addressed.