Fix India’s fragmented drug regulation
India’s approval and regulatory system for
drugs and pharmaceuticals is dysfunctional. A recent report by Dinesh Thakur,
Ranbaxy whistle-blower and health activist, points out shortcomings
and glaring anomalies in our oversight system for drugs and pharma, which need
to be promptly rectified.
We have a hugely fragmented drug regulatory
framework, with as many as 36 state and Union territory licensing authorities,
whereby a pharma manufacturer can garner a licence in one state and distribute
its product nationally. It follows that any laxity, say, a batch of Not of Standard
Quality (NSQ) drug anywhere can have national and even international
repercussions. The report cites studies which show that substandard and NSQ
drugs can be as high as a fifth or more of all medicines procured locally. The
Central Drugs Standards Control Organisation (CDSCO) and the state authorities
are supposed to carry out routine testing of drug samples, but the report finds
the statistical methodology followed to be “vague” and mostly nontransparent.
This cannot continue.
We need to overhaul the oversight regime,
given India’s potential to be the pharmacy of the world. The Thakur report is
categorical that there is no mechanism to ensure a nationwide withdrawal of a
bad batch once it is established as being NSQ in a particular state. A more
centralised regulatory system is possible by simply amending Rule 69 in the
Drugs & Cosmetic Rules, 1945, the report avers. It also calls for a
national NSQ database to vet credibility of manufacturers, and stresses the
specific need for a public procurement law to regulate and mandate standards in
the procurement of medicine. The bottom line is that proactive pharma
regulatory reform would boost wellness, trade and the overall growth momentum.
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