Terra pharma: A new drugs legislation must keep the pharma sector growing while safeguarding consumer interest

Synopsis: Pharma ecosystem is rapidly evolving and needs proper monitoring and regulation.

Introduction

The Union government has constituted a committee for framing draft legislation regarding new drugs, cosmetics and medical devices.

What is the performance of Indian Pharma at global level?

Indian Pharma industry is ranked as the second-largest in terms of workforce. It is ranked as third in terms of production volumes. Furthermore, It is also ranked as 14th in terms of global value.

The Economic Survey 2020-21 also estimated a threefold growth for the pharma industry from its $40 billion current market size by the end of this decade.

What is expected in the new law?

Consultation: It will have to be framed after consulting all the leading industry voices and health experts.

Uniform standards: It will seek to address one of the major flaws of the present regime is the dual regulation by CDSCO (Central Drugs Standard Control Organization) and the states. The new law will enforce uniform standards to prevent malpractices in the system.

Uncertain Regulatory environment: E-pharmacies are adjusting and evolving after the recent regulatory and judicial declarations. Still, the risks like forged prescriptions continue.

Even in Brick and mortar shops, the risks like the sale of over-the-counter antibiotics and Schedule H drugs continue. The new law has to properly regulate these instances.

India needs a mature pharma ecosystem where the entire chain from prescription to sale of drugs is monitored. The new law must streamline manufacturing rules, quality control and R&D norms to help Indian companies meet new challenges.

Source: This post is based on the article “Terra pharma: A new drugs legislation must keep the pharma sector growing while safeguarding consumer interest” published in The Times of India on 9^th September 2021.