‘Suggestions not accepted’: Bill to overhaul drugs law faces opposition from pharma, medical device sector
Source Entity
Anonna Dutt
The proposed overhaul of India's 1940 Drugs and Cosmetics Act faces backlash from the medical device sector due to a lack of stakeholder consultation. Industry bodies argue the current draft fails to provide the necessary regulatory framework for global competitiveness.
Regulatory Overhaul Stalls Amid Industry Pushback
The Indian healthcare landscape is currently witnessing a significant legislative friction point as the proposed bill to overhaul the colonial-era Drugs and Cosmetics Act, 1940, encounters stiff resistance. Stakeholders from the pharmaceutical and medical device industries have voiced intense concern over the draft, which is currently undergoing internal review among various government ministries. The core of the dissatisfaction lies in the perception that the legislative process has been exclusionary, effectively sidelining the very industries it seeks to regulate.
The Consultation Deficit
A primary grievance cited by industry associations is the complete lack of meaningful stakeholder consultation during the drafting phase. Representatives from both the pharmaceutical and medical device sectors have highlighted that the current text is largely a iteration of drafts circulated in 2022 and 2023, featuring only cosmetic modifications. This perceived lack of transparency has fueled frustration, as stakeholders feel their previous inputs were ignored, leading to a bill that remains disconnected from the ground realities of modern medical manufacturing.
The Medical Device Dilemma
The Association of Indian Medical Device Industry (AiMeD) has taken a formal stance, writing to Union Health Minister J P Nadda to express their grievances. The association argues that the bill, in its current form, fails to establish the robust regulatory foundation essential for the sector to achieve scale, foster domestic innovation, and compete effectively on the global stage. By treating medical devices as an adjunct to drugs rather than a distinct category, the legislation may stifle the growth of a segment that is vital for India’s healthcare self-reliance.
Historical Context and Legislative Lag
For decades, the Drugs and Cosmetics Act, 1940, has served as the bedrock of Indian health regulation. However, as medical technology has evolved, the monolithic nature of the act has become increasingly problematic. The attempt to modernize this framework is a recognition that the current system is outdated; however, the failure to decouple medical devices from pharmaceutical regulation remains a point of contention. The industry's demand for a specialized, standalone regulatory framework is rooted in the unique lifecycle and safety requirements of medical hardware compared to chemical compounds.
Implications for Global Competitiveness
If the government moves forward without addressing these industry concerns, the long-term implications for India’s medical device sector could be profound. A regulatory environment that does not differentiate between medical devices and drugs risks imposing excessive compliance burdens that could hinder domestic startups and established manufacturers alike. As India aims to position itself as a global hub for medical manufacturing, a failure to modernize the regulatory framework could result in missed opportunities for exports and foreign investment.
The Path Forward
The ongoing impasse highlights the delicate balance between public safety and industrial growth. Moving forward, the Ministry of Health faces the challenge of reconciling these industry demands with its public health mandate. Whether the government chooses to re-open the draft for a more inclusive consultative process or proceeds with the current version will determine the future trajectory of medical device regulation in India, potentially setting the stage for either a collaborative legislative success or a period of prolonged industry uncertainty.