India's Pharma Sector Faces Scrutiny as NITI Aayog Demands Change

NITI Aayog requested across-the-board quality makeover of India's pharma industry, while top industry bodies rang alarm bells on systemic issues that are stifling compliance with international standards. The meeting, led by Dr. VK Paul, Member (Health), was on keeping India in line with global standards in pharma manufacturing and improving patient safety while reinforcing public health confidence.

The meeting united the major stakeholders, namely the members of the Indian Pharmaceutical Alliance (IPA), Indian Drug Manufacturers' Association (IDMA), Bulk Drug Manufacturers Association (India), Organisation of Pharmaceutical Producers of India (OPPI), and some MSME-based associations.

The highest priority of the agenda was to find bottlenecks in manufacturing high-quality, world-acceptable medicines and to outline a coordinated approach to regulatory reform. NITI Aayog stressed maintaining India as the "pharmacy of the world" by investing in strong quality standards in its chain of more than 10,500 plants.

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Industry executives spoke of increased volumes of Not of Standard Quality (NSQ) notices, citing most as a result of inadequate technical education and regulatory knowledge. Industry executives attributed below-par pharmacy schooling as a root cause, producing under-qualified staff that is unable to pass inspection.

MSME delegates, specifically from Confederation of Indian Pharmaceutical Industry (CIPI), discussed the suffering of carrying out stability studies with limited budgets. They urged the government to provide sectoral assistance for the upgradation of infrastructure and asked for special policymaker-MSME association dialogue meetings.

The session emphasized a common objective, enhancing drug quality, but it underscored ingrained working issues that require long-term, stakeholder-led solutions.