Acting on the reports of the Prof Ranjit Roy Chaudhury committee which had recommended to ban all the hazardous and irrational drugs in the pharmaceutical market in the country, the Union health ministry has decided to ban the continued marketing of such drugs in the country which were banned by two or more countries in the world.

“It has been decided that if two or more countries remove a drug from their market on grounds of efficacy and safety, then the continued marketing of the drug in the country will be considered for examination and appropriate action”, the health ministry said.

Earlier in February last year, the ministry had constituted an expert committee under the chairmanship of Prof Ranjit Roy Chaudhury to formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs. After much deliberations, the committee submitted its recommendations in September, 2013, recommending sweeping changes in all these sectors.

The committee, in its report, noted with concern that in India there are unacceptably large number of formulations in the market at present, somewhere between 60000 and 85000, and many of these medicines should not have been allowed to reach the market in the first place.

Drugs which should never have been allowed to reach the market are being marketed.  Many of these drugs are inherently unsafe and potentially hazardous. They do not appear in any textbook of medicine or pharmacology; nor do they find a place in the market of any country which has a well-regulated market for drugs. Such drugs must be removed from the market, the committee had noted in its report.

The committee had further noted that new drugs should be allowed to be marketed in the country only if the experts feel that the drug will have some advantages over the already existing drugs in terms of therapeutic efficacy and safety.  Another consideration is whether the drug is being marketed in the country of origin. If not, then questions arise as to why this is so, and this becomes a factor in approving its release in India.

“Again, if the drug is already in the market but two or more countries remove the drug from their market on grounds of efficacy and safety, then the national drug regulatory agency should consider the possibility of removing the drug from the Indian market as well”, the panel recommended.