Expired pill: Editorial on new drugs and cosmetics bill
This month, the Union ministry of health published the draft new drugs, medical devices and cosmetics bill to replace the antiquated Drugs and Cosmetics Act, 1940. Yet, most of the draft bill appears to be a copy of the old law. Perhaps the gravest oversight in both the Act and the draft bill is a lax regulatory process. There is no mention of compliance with ‘good manufacturing practices’ — a global standard when it comes to testing drugs — or the need to make inspection reports public, leaving the process of regulation vague and dependent on the whims of drug inspectors. Lack of transparency on decisions such as approving a new drug or a manufacturing facility — both of which can have huge implications for public health and profits of the pharmaceutical industry — leaves the door open for irregularities like the falsification of data and test results. That is not all. The Covid-19 pandemic highlighted several infirmities in the pharmaceutical sector. The draft bill could have been a perfect opportunity to address these. For instance, ‘open source vaccines’ — generic versions of the vaccines already being used successfully — could have ensured that more people got access to the life-saving drugs. This would require waivers on intellectual property rights by pharmaceutical companies. Since the earliest stages of research and development often rely on substantial public sector investment, the government might have reserved the right to waive off IPR in an emergency. This lapse is even more surprising as India had recently proposed to the World Trade Organization to waive off IPR obligations to address shortages of products required for the prevention, control and treatment of Covid-19.
Another issue that has come up in every review of the drug regulatory system since 1947 has been the uneven enforcement of the DCA, since state drug controllers are expected to license drug manufacturing, conduct sampling and testing, and to prosecute for substandard drugs. Disparities in laws, as well as checks and balances across states, create challenges when it comes to maintaining a uniform standard for drugs. There are other inconsistencies. The new bill has brought Ayush under its purview without elaborating on the penalties for spurious ayurvedic products. The definition of and punishment for manufacturing ‘spurious’ allopathic drugs are, on the other hand, quite clear. Modern regulatory systems typically guarantee citizens the right to participate in decision-making. The draft bill — a sign of the times? — has no such provision.