News

NITI Aayog’s High-Level Meet Puts Spotlight on Drug Quality, Regulatory Gaps, and MSME Challenges in Pharma Sector

The consultation was part of NITI Aayog’s broader effort to preserve India’s position as the “pharmacy of the world” while ensuring the safety and trust of domestic consumers through strengthened quality assurance.

• By Newsdesk
• New Delhi
• Jul 08, 2025

News

In a significant push toward raising pharmaceutical manufacturing standards in India, NITI Aayog convened a high-level consultation on Monday to address pressing concerns surrounding drug quality, regulatory enforcement, and systemic constraints across the sector. The meeting, chaired by Dr. VK Paul, Member (Health), aimed to chart a roadmap to bring India’s pharmaceutical ecosystem in line with global benchmarks.

Held at NITI Aayog headquarters, the discussion brought together key pharmaceutical industry bodies to deliberate on persistent challenges that hinder the production of high-quality, globally acceptable medicines. The consultation was part of NITI Aayog’s broader effort to preserve India’s position as the “pharmacy of the world” while ensuring the safety and trust of domestic consumers through strengthened quality assurance.

The meeting invitation, circulated to leading associations including the Indian Pharmaceutical Alliance (IPA), Indian Drug Manufacturers’ Association (IDMA), and Organisation of Pharmaceutical Producers of India (OPPI), emphasised the need to focus rigorously on quality to safeguard public health and bolster global credibility.

Concerns Over NSQ Drugs and Skill Deficits

One of the most critical issues raised during the consultation was the rising number of Not of Standard Quality (NSQ) drug alerts. Industry representatives attributed this trend to technical skill gaps within the workforce, particularly stemming from inadequate training in pharmacy education. This, they noted, impacts the ability of manufacturing units to maintain quality standards and respond effectively to regulatory inspections.

A recurring concern was the shortage of qualified technical personnel, which many believe directly affects manufacturing efficacy and compliance with Good Manufacturing Practices (GMP).

MSME Sector Seeks Tailored Policy and Infrastructure Support

Micro, small, and medium pharmaceutical enterprises (MSMEs), represented by the Confederation of Indian Pharmaceutical Industry (CIPI), highlighted structural disadvantages, including financial and infrastructural limitations that hinder their ability to conduct vital stability studies and maintain quality standards. Industry members called for dedicated government support, including targeted funding, infrastructure grants, and direct engagement with policymakers to address sector-specific bottlenecks.

Contrary to prevailing perceptions, MSME advocates strongly contested the narrative that smaller firms are primarily responsible for quality failures. They argued that larger corporations, despite frequent international regulatory setbacks, often escape scrutiny in India. Citing data on drug production and NSQ rates, MSME leaders asserted that small manufacturers produce the vast majority of India’s drugs with minimal deviations.

Pricing Pressures and the Cost of Compliance

Another area of concern was the impact of stringent price controls on manufacturers’ ability to invest in quality upgrades. Industry participants pointed to examples such as cotrimoxazole, a key antibiotic that has reportedly disappeared from the domestic market due to unviable pricing, as evidence of the growing tension between affordability and quality.

While companies expressed their willingness to adopt higher standards and invest in improved infrastructure and talent, they cautioned that these efforts come at a cost. With little flexibility in pricing, several manufacturers are being forced to discontinue essential drugs, raising questions about long-term sustainability and access.

Regulatory Push for Stringent Enforcement

The Drug Controller General of India (DCGI), Dr. Rajeev Singh Raghuvanshi, reaffirmed the regulator’s uncompromising stance on enforcing Good Manufacturing Practices. In a message delivered during the meeting, he outlined plans for a stricter accountability framework, including license suspensions for NSQ cases following a two-week show-cause period, with reinstatement contingent on corrective action reviews.

He also urged pharma associations to play a more proactive role in guiding member companies towards consistent quality adherence, underlining that self-regulation must complement state oversight.

Amid ongoing debates around Indian Pharmacopoeia (IP) versus WHO-GMP norms, the DCGI clarified that both standards should be viewed as complementary rather than conflicting, reinforcing the government’s intent to harmonize domestic practices with global systems.

The meeting reflected a broad consensus on the urgent need for reform, with government officials encouraging industry participants to submit their inputs in writing for further consideration. The dialogue is seen as a step toward more collaborative policymaking, with a clear emphasis on elevating India’s pharma quality standards without compromising the sector’s accessibility or growth potential.

As India seeks to maintain its global leadership in pharmaceuticals, the outcomes of this consultation could shape the regulatory and operational future of one of the country’s most vital industries.