AIDCOC demands suspension of marketing approvals granted to 33 drugs without trials
Expressing concern over the critical situation made out by the Central Drugs Standard Control Organisation (CDSCO) by granting permission to market 33 drugs without carrying out clinical trials in India, the All India Drugs Control Officers’ Confederation (AIDCOC) has demanded the union health ministry to suspend the approval granted to these drugs for sale in India with immediate effect.
Castigating the CDSCO for its connivance with pharmaceutical companies whose unscrupulous nexus with the medical experts helped them to get clearance for the drugs, AIDCOC wanted the union health minister to conduct a thorough investigation in the case in the interest of the common public.
Coming down heavily on the central drug licensing agency’s role, Revi Uaday Bhaskar, the secretary general of AIDCOC said it is high time the government cancelled the manufacturing and sale licences of the drugs and action taken against the culprits. He said since parliamentary standing committee on health has brought out the collusive nexus, it is the bounden duty of the union government to conduct a thorough investigation on the issue. He wanted the minster to withdraw the licences granted to the manufacturers of the drugs.
While welcoming the initiative taken already by the union health ministry to look into the matter, Uday Bhaskar further criticized the central drug control organisation that its non-commitment to public health has made the country a testing field for many a drug like nimesulide which is banned in 123 countries, but marketed in India. He told Pharmabiz that even its innovator, Boehringer, did not get an marketing approval from the US FDA but being marketed in India. These all happen in India because of the unholy trinity, the CDSCO, medical experts and the manufacturers, he told Pharmabiz.
Commenting that action against the drug marketing and manufacturing companies cannot be compromised, the AIDCOC secretary general said his confederation would apprise the union government of the severe consequences arising out of the lapses of the controlling agencies. “The nexus between the manufacturers and the medical experts have to be brought into light. The responsible officers’ intrigue should be investigated and punished the guilty. Our association will not remain as a silent observer to these callous incidents,” Uday Baskar told Pharmabiz.