Even as several controversial drugs are being reviewed by different sub-committees of the DTAB to take a decision on banning them in the country and several of them are being considered for bringing under the national pharmacovigilance programme to register their adverse reactions, experts have raised concern over the entire exercise by the DCGI as they view it as a delaying tactics.
According to experts, while the Drug Controller General of India (DCGI) approves a drug without taking advice from the DTAB, the DCGI should take an independent view on banning it in public interest. In the Drugs and Cosmetics Act, the DCGI has the power to approve a drug as well as the power to ban a drug, keeping in mind the overall interest of the people of the country, experts said. The appointing authority should also be the dismissing authority in the entire world in all matters.
“This is a wrong practice to refer the matter to the DTAB as it will only help the matter prolong. There are several examples in the past when the then DCGI banned a drug without referring the matter to DTAB. Rafecoxib (indicated for pain killer), Fenformin (indicated for diabetes), Astemizole and Terfinadine (both anti-allergic drug) were all banned by the then DCGI without consulting the DTAB. After all, the decision of the DTAB is not binding on the DCGI,” said Dr CM Gulhati, well-known health expert and editor of the medical journal MIMS.
Urging the authorities to be transparent and uniform in application of law, experts, who do not want to be quoted, said that there should not be different yardsticks for different drugs, as some drugs will be banned by the DCGI and some others will be left to the DTAB just to help to prolong a decision.
The recent cases of advertisements on two brands of morning-after-pills 'Unwanted 72' and 'I-Pill' (and more recently, the case of GSK's ad on cervical cancer vaccine) are the examples how the companies would benefit from the authorities' indecision. The advertisement blitzkrieg on 'Unwanted 72' and 'I-Pill' continued for over a year before DTAB advised the government to ban it. But by the time the authorities acted, the company's purpose is already served.
Several controversial drugs, which were banned in the developed nations like US, Canada and European Union nations for adverse health effects and are being sold in India freely, are being re-examined by the DTAB. The drugs include popular non-steroidal anti-inflammatory drug Nimesulide, anti-depression drug Deanxit, decongestant phenylpropanolamine, antibiotic drug gatifloxacine and infertility drug letrozole.
Nimesulide is a case in point. The drug is not approved for use in US, Britain, Canada, Sweden, Denmark, Australia, New Zealand, Japan and other 168 countries. But it is available in India under the brand names Nise (Dr Reddy's) and Nimulid (Panacea Biotech). While the DCGI accepts the foreign data for approving a drug, he will not accept the foreign data for banning a drug and instead refer the matter to the DTAB, Dr Gulhati said. After the prolonged exercise, they will ban some drugs which otherwise have also not much market in the country like the recently banned drug Rimonabant, he added.