The All India Drugs Control Officers Confederation (AIDCOC) is planning to send a draft representation to Rajya Sabha objecting the Drugs and Cosmetics Amendment Bill 2013.
Highlighting objections raised by various state drug control administrations and other concerned stake holders like state drug control associations, bulk drug manufacturers association (BDMA), pharmaceutical industry and the consumers, the AIDCOC, general secretary, Ravi Uday Bhaskar, has compiled a comprehensive draft representation with objections to be sent to Joint Director Rajya Sabha.
According to Uday Bhaskar, the central government’s move to establish Central Drug Authority in the guise of strengthening the Drug control Administration serves no purpose except centralising the power which in turn will create regulatory hardships and delays in licensing and supervision. He says the central government has misinterpreted the Mashelkar Committee report for strengthening state and central drug control administration. He opined that instead of vesting enormous power with the CDSCO, the government should concentrate on strengthening the already existing administrative set up at the state and central levels.
Pointing out various examples of regulatory inefficiency exhibited by Central Drugs Standards Control Organisation (CDSCO) on earlier counts, Uday Bhaskar said, “Going by the recent actions of CDSCO it shows they are functioning in confused state and ineffective manner. Recently they banned pioglitazone which drew widespread condemnation from pharmaceutical industry. The drug was banned without even consulting the Drug Technical Advisory Board and after much hue and cry the ban was revoked, but the confusion prevails till date among the physicians and the patients. Moreover the track record of the CDSCO as CLAA in clearing the files of blood banks reveals inordinate delay in grant and renewal of licenses, in some cases it took more than seven to eight years.”
Further highlighting the inefficiency of CDSCO the General Secretary pointed out the recent indictment by parliamentary standing committee against CDSCO for approving 31 new drugs without conducting phase-II clinical trials on Indian patients.
Keeping all these in mind the all India drugs control officers confederation is mobilising all the state drug controller administrations and has even taken into confidence various state drug control associations and pharma manufacturers to oppose the drugs and cosmetics amendment bill 2013.