The How of 'Schedule Y'

Last week the Supreme Court of India pulled the brakes on a thriving drug trial industry in India.

Valued at over $300 million a year this industry was engaged in a rather unusual business. Big pharmaceutical MNCs spending billions of dollars in the discovery of New Chemical Entities (NCEs) would conduct their first human-level trials in countries like India. If the new drugs turned out to be blockbusters, the chances of their being available to patients in India was next to zero.

Out of 475 global clinical trails conducted from 2005 to 2012 using Indian patients, only 17 patented drugs were freely available for the  participants. This is doubly significant because it was in 2005 that Indian pharma laws were amended to allow 'concurrent' testing of NCEs. With this removal of a phase-lag in the testing regime, drugs of  unproven safety and efficacy could be tested on patients in this country.

So it came as not surprise that on 3 Jan., 2013, the Supreme Court directed the Central Drug Standards Control Organisation (CDSCO) to put in place a three-tier scrutiny of all clinical trails. Drugs & Cosmetics Rules already had a separate section - Schedule Y - setting the procedures for such trails but they were never really implemented.

Even after the SC directive, for the next 10 months neither CDSCO nor the health ministry did  to improve the safety of Indians participating in these trails. Taking note of this tardy response, on 21 October 2013, the court has ordered the government to stop all 'concurrent' clinical trails.

Even though this affects only 331 or 1122 trails (30%); and even though our gains from these trails were limited (no patent rights, no affordable drugs) it is interesting to see the MNC pharma lobby portraying this as a zero-sum game where 'India's loss is Bangladesh's gain'!

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LINKS & REFERENCES

* Mascarenhas, Anuradha (2013): DRUG TRAILS - LAX REGULATIONS COST THE COUNTRY DEAR, Indian Express, 25Oct13

* Jesani, Amar (2013): TRIED, TESTED AND FAILED, Indian Express 28Oct13

* Schedule Y -- http://cdsco.nic.in/html/D&C_Rules_Schedule_Y.pdf