In a controversial move, a high-level panel of the Drug Controller General of India (DCGI) has recommended that drugs being sold in the markets of well-regulated countries for four years should be allowed in India too, even if no clinical trial has been conducted on the Indian population.
This is contrary to the current regulation, according to which drugs can be given marketing licence only after their safety and efficacy is proved in a clinical trial on local people.
The panel, headed by Professor Ranjit Roy Chaudhury, former member of the Board of Governor of the MCI, said that the drugs “with a good post marketing surveillance (PMS) for more than four years and which have a satisfactory report may also be permitted for direct marketing in India, subject to strict PMS for four to six years or after bridging studies, on a case-by-case basis.”
According to the report, ‘Formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs’, the
Chaudhury panel has also called for reducing or waiving the period of four years in cases where no therapy or only palliative therapy is available, or in national healthcare emergencies, says the panel.
However, the suggestion is in variance with observations of the Parliamentary Standing Committee on Health, that had recently asked DCGI to withdraw drugs which it had wrongly approved without any clinical trials on local population. In fact, the DCGI was pulled up for this.
The Union Health Ministry too had admitted that as many as 26 new drug molecules were approved since 2010 without testing them through drug trials on local populations.
Clearly, the Chaudhury panel seems to be ignorant of the House panel’s observations.
“The DCGI panel’s suggestion is highly unacceptable. How can it think of allowing drugs for Indian population which have been tested on foreignersIJ What about ethnic differencesIJ” said CM Gulati, editor of the MIMS, a reputed journal on drugs.
He also feared that such a recommendation would effectively mean that foreign companies wait four years to enter India without clinical trials on locals.
Joint Secretary (Health) AK Panda said he was yet to see the report. He also pointed out that the suggestions are not binding on the Health Ministry.