The legislation must provide the framework for an effective regulatory structure. The draft Bill persists with the current system where the Central Drugs Standard Control Organisation (CDSCO) oversees imports, approvals for new drugs and manufacturing licences for a limited number of drugs, while state regulators oversee manufacturing licences and pharmacies in the state. This overlap in jurisdictions adversely impacts compliance. The new law is an opportunity to put forward a system where the central and state regulators work in unison and serve as a checks’n’balances mechanism. The Bill fails to give the drug regulator statutory backing that other sectoral regulators have. An autonomous statutory body requires to be properly staffed with qualified professionals for it to be effective. Another area where the draft falls short is in providing robust regulatory structure for clinical trials. The structure that the draft outlines is basic and does not guarantee transparency, while concentrating power in a central licensing body.
In its current avatar, the New Drugs, Medical Devices and Cosmetics Bill is an exercise in perpetuating existing infirmities. The pharma industry and public health need a robust legislative framework, and GoI would do well to provide that.