Union government should take a serious view on the existence of large number of branded drugs as these branded drugs are in market despite government directions against them. The Drugs Controller General of India (DCGI) on October 1, 2012 under section 33(P) of Drugs and Cosmetics Act, has intimated all state health secretaries and drugs controllers to grant and renew manufacturing licenses of drug formulations in proper generic name only said, Dr BR Jagashetty, former national advisor ( drugs control) to ministry of health & family welfare, and former Karnataka drugs controller.
While licenses for generic drugs are granted by the state licensing authorities (SLAs), brand names can also be seen on the packs. The National Pharmaceutical Pricing Authority (NPPA) fixes prices of brand names along with generic drugs. It needs to be verified as to who would have permitted to manufacture these drugs. The government will need to take a speedy decision on whether it is the CDSCO or SLA to inspect and verify the brand names, pointed out Dr Jagashetty.
When the DCGI has issued a conditional norm that suitable licenses are to be issued to the original manufacturer and the loan licensees for production of generic drugs only, there was no way such medicines under brand names could be marketed. But the reality is that huge presence of different brand names in same fixed dose combinations (FDCs) manufactured and marketed can be seen, he added.
Manufacturers with valid generic drug licenses are producing FDCs in different brand names at the same production facility and its addresses coexist. These are marketed by the same companies or by others and sold under different MRP. It is not clear how such things are being permitted. For instance: FDCs containing chlorpheniramine maleate 4mg and codeine phosphate 10 mg per 5ml were approved by a former DCGI to some manufacturers. It is also found that cough syrups in the FDC of chlorpheniramine maleate 4mg, codeine phosphate 10 mg, and alcohol 0.15 ml per 5ml are also in market under brand names: Tossex Cough Syrup and Trustyl-CD Cough Syrup with huge variations in MRP.
Suitable guidelines need to be issued or amendment may be made under the D&C Rules to restrict such practices including that of third party manufacturers.
Further, contract manufacturing must be discouraged. But manufacturing under loan licences could be granted as per the D&C Rules. There is no provision under Rule 96, 97 to label the drug as ‘Marketed By’. Further, it is also observed in many cases drugs are labelled as ‘Mfd. By’ and ‘Marketed By’ and sold by manufacturers under sale invoices to the marketer not in the address as printed on the label.
Guidelines are required for third party manufacturing on party-to-party agreement basis. It should insist on accountability of both companies if the drugs are detected to under substandard or banned category, he said.