Terra pharma: A new drugs legislation must keep the pharma sector growing while safeguarding consumer interest
GoI’s move to draft a new law for drugs, medical devices, cosmetics and e-pharmacies recognises changing dynamics in the pharmaceutical sector, which the 1940 vintage Drugs and Cosmetics Act was inadequately addressing. DCA and its rules, through many amendments and periodic revisions, witnessed Indian pharma globally ranking third in terms of production volumes (14th in value) and become second largest in terms of workforce. Economic Survey 2020-21 estimated threefold growth for the industry from its $40 billion current market size by this decade’s end. The DCGI-headed eight-member panel drafting the new law must ensure that leading industry voices and health experts are extensively consulted. Among the present regime’s major flaws is the dual regulation by CDSCO and states. This allows malpractices wherever state officials look the other way. Given the large pharma ecosystem, comprising several thousand drug companies and manufacturing units, enforcing uniform standards and preventing circulation of substandard drugs and devices is impossible with disjointed regulatory outlooks. The Ranbaxy manufacturing malpractice episode was one among quite a few reminders that Indian pharma’s reputation and exports need continuous quality manufacturing.
At the retail end, e-pharmacies are steadying after conflicting judicial decisions and an uncertain regulatory environment on online drug sales. Still, foreign investors would need more statutory clarity even as public health worries over forged prescriptions linger. But with many traditional brick-and-mortar pharmacies operating without licensed pharmacists, regulating the retail end needs a rethink. Consumer interest will also be served well by indemnity protection especially after the J&J hip implant mishaps. Plus, over-the-counter antibiotic and schedule-H drug sales remain a serious issue. A mature pharma ecosystem means prescriptions must become the norm. With the Covid pandemic, nations are recognising a robust domestic pharma sector’s importance. The new law must streamline manufacturing rules, quality control and R&D norms to help Indian companies meet new challenges.
Source – TheTimesOfIndia