WHO Audit, India Hopes, Will Restore Shine To Its 'Pharmacy Of The World' Image

(MENAFN- Live Mint)

India plans to get its drug regulatory system audited and rated by the World Health Organization (WHO) to detect specific strengths and weaknesses that will help to make it fool proof, according to four officials and a document reviewed by Mint.

The move comes after multiple instances of drug safety related incidents in the country as well as export markets raised serious questions on the quality of medicines made in India, often referred to as 'pharmacy of the world'. India faces multiple challenges in drug quality given the sheer scale of the industry, comprising thousands of manufacturers regulated by varying state-level standards.

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Under the proposed assessment, WHO will evaluate India's regulatory system to assure the quality, safety, and efficacy of medicines and rate the overall 'maturity' of a regulatory system on a scale of 1 to 4. The assessment by WHO is treated worldwide as a gold standard for medicine quality and is often used in global tenders to purchase drugs.

“The WHO has been insisting on this quality control assessment for medicines for a very long time. While this benchmarking is conducted globally, in India, it is currently limited to vaccines," said one of the four officials, all of whom did not want to be identified in this story.

“Under this framework, the WHO rigorously assesses core regulatory functions-such as inspections, approvals and enforcement actions-to rank the national system against standard parameters and suggest improvements. At present, India does not possess such a ranking for its general pharmaceutical regulatory system," the official said.

Based on WHO's findings, the Central Drugs Standard Control Organisation (CDSCO) can address the weaknesses in the regulatory system.

India has already achieved success with this approach in the vaccine sector. In 2024, the WHO assessed India's vaccine safety systems and awarded it a“Maturity Level 3" rating-a high ranking confirming the system is stable and functional. Now, regulators want to replicate that success for general medicines.

“India has achieved WHO Maturity Level 3 for vaccine regulation, but we currently lack a similar ranking for general medicines. In light of recent incidents involving poor-quality drugs-particularly cough syrups in both domestic and overseas markets-India's absence from these pharmaceutical rankings is a significant concern. That is why there is now such a strong focus on addressing this gap," said a second official.

Strong regulation provide a protective umbrella to public health, WHO said in a statement to Mint, adding it has done several evaluations of India's regulatory framework over the years“Last month (November 2025), WHO and CDSCO jointly held workshops on regulatory performance indicators and advanced GMP inspections, reinforcing India's capacity to ensure the quality, safety, and efficacy of medical products," the statement noted.

“India has raised the bar on safety and quality by investing substantial national resources to strengthening National Regulatory Authority and upgrading manufacturing facilities with revised Good Manufacturing Practices" in line with WHO's standards, the health organization added.

Centre-states regulatory challenges

Instances of contaminated, poor and unsafe quality of drugs manufactured in India, specifically cough syrups, have been linked to deaths of children in India and abroad. In 2022, approximately 70 children died in Gambia and 18 in Uzbekistan and, in India, a tragedy in late 2025 claimed the lives of over 20 children in Madhya Pradesh and Rajasthan.

The move to rope in WHO is expected to correct the sullied image of India's $50 billion pharmaceutical market and speed up the qualifying process in certain export orders.

India is the world's largest supplier of generic medicines, exporting over 20% of global volumes to more than 200 countries and regions, including the US and EU. Exports stood at $30 billion in FY24-25, as per Pharmexcil, India's pharmaceutical export promotion council.

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Dr Sangita Reddy, joint managing director, Apollo Hospitals Group, called the government move proactive.“With initiatives like 'Heal in India' (medical tourism), 'Heal from India' (medicine exports), and 'Heal by India' (medical workforce), we are building India as a global brand for healthcare and the pharmaceutical industry is the anchor for this mission. We will do whatever we can to cooperate," she said.

Yet, enforcing strict standards nationwide is challenging because drug rules are enforced differently across states. To address this, the government has devised a flexible plan. Instead of mandating a simultaneous upgrade for every state, the regulator is asking states with already robust systems to volunteer first for the WHO assessment.

Last month, the Drug Consultative Committee, an advisory body under apex regulator Drug Controller General of India to coordinate between regulatory agencies at the centre and states, deliberated the matter and recommended a consultation meeting for manufacturing states and union territories along with WHO officials in this regard.

“This proposal was discussed last month in a meeting chaired by the DCGI. It is a positive initiative that states can adopt voluntarily, as they manage their own budgets. We are currently reviewing the roadmap for implementation," a third official said.

This official added that while the parameters defined for vaccines would be replicated for medicines, state acceptance remains crucial.“This is a mammoth task given that India is a major generic drug producer catering to vast markets globally. It will require significant manpower, financial resources, and teamwork involving WHO officials and subject experts, because implementing WHO audits for medicines is not going to be an easy task," the official noted.

Dr Y K Gupta, president of AIIMS Kalyani and former head of pharmacology at AIIMS Delhi, emphasized the urgency of nationwide adoption.“In my opinion, all states and union territories must participate. This ensures our population receives assured quality medicines while signaling to the globe that robust controls are in place," he said.

The WHO edge comes with a reset of processes

Notably, international organizations like the United Nations rely heavily on the WHO to ensure the quality of medicines procured for regions such as Africa. Before floating tenders for critical drugs like HIV, TB, or malaria treatments, these agencies require WHO assessments to verify that manufacturers meet basic safety and efficacy standards.

To participate in these tenders, companies have to undergo a rigorous two-step registration process: the pharmaceutical company itself must register its products and undergo an on-site WHO audit, while the country's drug regulator must also be assessed for its effectiveness.

This regulatory evaluation examines key factors such as inspection manpower, testing laboratories, pharmacovigilance mechanisms, quality control, and the authority to act decisively in emergencies.

But, besides the centre-state regulatory challenges, there will likely be a challenge of scale in evaluating regulatory system for drugs. Unlike the vaccine sector, which involves a handful of companies, India has approximately 10,500 pharmaceutical manufacturing units operating in India, according to an answer in Parliament in March 2025. India manufactures about 60,000 generic brands across 60 therapeutic categories. There are about 500 active pharmaceutical ingredient (API) makers who account for about 8% of the global API industry.

“In India's drug system, several gaps remain regarding compliance with Schedule M (Good Manufacturing Practices), along with insufficient manpower and mechanisms for monitoring emergencies. For instance, the WHO requires inspection reports to be in the public domain-a practice not yet fully adopted in India," said a fourth official.

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Still, successful benchmarking would offer two major benefits, the official added.“First, enhanced vigilance: random inspections by the WHO would keep both regulatory agencies and pharmaceutical companies on their toes, ensuring consistent quality," the official said.

“Second, global reputation: If India-or even individual states-achieves WHO registration, it would significantly boost the country's image and give Indian medicines greater weight in the global market," the official added.

A senior pharmaceuticals company executive said the proposed assessment by WHO will reinforces India's reputation as a dependable, quality-centric supplier to the world. This move will harmonize quality systems and reduce variability across manufacturers, mirroring the success seen in our vaccine ecosystem," said Parag Bhatia, director at Laborate Pharmaceuticals. "For generic manufacturers, this upgrade means faster approvals and the ability to participate in high-value global tenders."

Queries sent to the health ministry spokesperson and drug controller's office on Monday remained unanswered till press time.

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