New Delhi – In a decisive move to elevate India’s pharmaceutical manufacturing standards, NITI Aayog recently convened a high-level consultation with key industry bodies to address mounting quality concerns and systemic gaps across the sector.
Chaired by Dr. V.K. Paul, Member (Health), the closed-door meeting gathered policy-makers, pharmaceutical associations, and MSME representatives to align India’s drug production ecosystem with global quality benchmarks such as WHO-GMP.
But while the government emphasized a zero-tolerance stance on substandard drugs, industry stakeholders urged a more balanced regulatory ecosystem that supports infrastructure, manpower development, and pricing reforms—particularly for Micro, Small, and Medium Enterprises (MSMEs).
Growing NSQ Alerts Underscore Skill and Education Gap
Rising instances of Not of Standard Quality (NSQ) drug alerts have become a flashpoint. Industry voices attributed this trend to technical manpower shortages, stemming largely from poor academic standards in pharmacy colleges.
“Under-qualified graduates lack the training to meet GMP audit expectations. This has a direct effect on compliance and drug quality,” shared an official from a leading pharmaceutical body.
MSMEs Seek Infrastructure Grants & Targeted Engagement
The Confederation of Indian Pharmaceutical Industry (CIPI) stressed that the MSME sector is disproportionately burdened by infrastructure deficits, especially around conducting mandatory stability studies—a cornerstone of drug quality assurance.
Industry stakeholders called for:
- Dedicated policy frameworks for MSMEs
- Financial aid schemes to support quality upgrades
- Regular consultation mechanisms with policy-makers
Adding perspective, Laghu Udyog Bharati challenged the dominant perception that MSMEs are the main source of quality lapses. Pointing to the frequent recalls by large corporations flagged by international regulators like the US FDA, the group called for equitable scrutiny across industry sizes.
“MSMEs produce 97.3% of India’s drugs, yet only 2.64% fall under NSQ, and rarely with patient harm. We must stop vilifying the backbone of the sector,” said Dr. Rajesh Gupta, representing the MSME voice.
Drug Pricing Pressures Threaten Product Continuity
Another critical issue tabled was the price control policies enforced by the National Pharmaceutical Pricing Authority (NPPA). Pharma representatives argued that below-sustainable pricing is forcing companies to pull essential drugs—such as cotrimoxazole—off the shelves.
“We’re being pushed to invest in better quality while being unable to revise prices. That’s a recipe for product discontinuation,” said one participant.
This adds to the growing tension between quality enforcement and affordability mandates, raising questions about the long-term viability of public health supply chains.
DCGI Reinforces Strict GMP Compliance Protocols
Dr. Rajeev Singh Raghuvanshi, the Drug Controller General of India (DCGI), reiterated a firm stance on Good Manufacturing Practices (GMP) compliance.
According to sources, companies found violating quality norms will now face license suspension within two weeks of a show-cause notice, reinstated only after thorough Corrective and Preventive Action (CAPA) assessment.
The DCGI also:
Clarified that Indian Pharmacopoeia (IP) and WHO-GMP should be viewed as complementary, not conflicting
Urged pharma associations to ensure self-regulation among members
Industry Takeaway
For pharma professionals and decision-makers, the message is clear:
India’s drug manufacturing future hinges on quality assurance, talent upskilling, infrastructure investment, and pricing policy alignment.
The convergence of global compliance demands and domestic affordability pressures makes this a pivotal moment for India’s pharmaceutical landscape.
Industry representatives appreciated the openness of the session and confirmed that senior officials were receptive and patient during the discourse. Written feedback has been encouraged, marking a possible pathway to collaborative policymaking in India’s journey to becoming a global pharma leader—not just in volume, but in quality.