Opinion Piece, Editorial Respond To Parliamentary Report On India’s Drug Regulatory Agency
Below are summaries of an opinion piece and an editorial responding to a report (.pdf) from the Indian Parliamentary Standing Committee on Health and Family Welfare on India's drug regulatory agency, the Central Drugs Standard Control Organization (CDSCO).
- Roger Bate, Wall Street Journal's "Opinion Asia": "India's Ministry of Health announced emergency plans last week to prevent irregularities in how the government approves new medicines," Bate, a resident scholar at the American Enterprise Institute in Washington, D.C., writes, adding, "The sense of urgency comes after a ... parliamentary report which found that [CDSCO] officials ... colluded with pharmaceutical firms to speed up medicine approvals." He continues, "Such collusion is a problem, but the risk is that the government will waste energy tackling the wrong disease," noting that substandard medicines are a risk to patients and could create drug-resistant diseases. Bate concludes that "post-market surveillance should be prioritized in an emerging country like India" (5/17).
- Lancet editorial: "To say that India's drug regulatory authority, the [CDSCO] -- whose remit includes new drug approval, licensing of manufacturing facilities, and regulation of drug trials -- is not fit for purpose seems a gross understatement," the editorial states, adding, "A damning ... report from the Indian Parliamentary Standing Committee on Health and Family Welfare ... describes a vast, geographically disseminated organization that is dangerously understaffed: nine officers at headquarters deal with 20,000 applications, more than 200 meetings, 700 parliamentary questions, and 150 court cases per year." The editorial continues, "India should seize this opportunity to wipe the slate clean and form a new drug regulatory body" with the "philosophy of ... the protection of patients" (5/19).