India To Rewrite Drug-Quality Rulebook To Match US, EU, Japan Standards

(MENAFN- Live Mint)

New Delhi: India's $50-billion pharmaceutical industry is set for a quality overhaul, as the government is preparing to unveil new safety and quality standards to reinforce the country's reputation as a global leader in drug manufacturing and bolster trust in medicines made by domestic companies.

India is setting up new standards for 123 drugs, and updating them for another 200 medicines, as it aims to align with the benchmarks in the US, Japan and the European Union (EU), according to three government officials familiar with the matter and documents reviewed by Mint.

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To be released shortly, these legally enforceable standards, known as Indian Pharmacopoeia (IP) monographs, are detailed blueprints outlining a drug's identity, purity and strength. They were last updated in 2022.

The goal is to boost confidence in Indian-made medicines and help grow the country's pharmaceutical market. The initiative assumes importance, given India's role in supplying affordable medicines globally and being the largest supplier of generic drugs, accounting for 20% of the world's supply by volume.

Developed by the Indian Pharmacopoeia Commission (IPC), an autonomous body under the Union ministry of health and family welfare, the new standards will be for anticancer drugs including Dactinomycin and Fulvestrant injections, and Pomalidomide capsules, and antidiabetic drugs including Dapagliflozin, Vildagliptin and Metformin prolonged-release tablets.

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The new standards will also cover antiretrovirals, including Etravirine tablets; antibiotics, including Cefprozil and Cefuroxime Axetil; and antituberculosis drugs such as Bedaquiline. Other drugs include Prednisolone Oral Solution, Dexamethasone and Bacitracin Ointment.

“IP standards serve as essential parameters for testing and guiding manufacturers to produce safe and reliable medicines. The IPC is adding new monographs for 123 drugs, including new fixed dose combinations, complex generics, antibiotics, blood reagents, anticancer and antituberculosis drugs. At the same time, we're revising around 200 monographs based on stakeholder feedback, upgrading testing methods with advanced technologies and adding specifications for dissolution and related substances," said the first of the three government officials cited earlier, all of whom spoke on the condition of anonymity.

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Queries emailed to the health ministry and Indian pharmaceutical companies Lupin, Zydus, Cipla and Dr Reddy's Laboratories on Tuesday remained unanswered.

Birendra Singh, global quality head for Mankind Pharma, emphasized the critical role of IP monographs in ensuring the safety, efficacy and affordability of medicines.

“These standards provide robust testing methods that align the company's quality with global regulations. Adopting these monographs standardizes testing in a cost-effective way, ensuring consistent, high-quality products for patients without impacting pricing. For patients, this means every medicine undergoes rigorous testing to guarantee purity, efficacy and safety, with the same reliable standards applied across the Indian pharmaceutical industry," said Singh.

The proposed standards will serve as a quality and safety benchmark for all medicines manufactured in India and 14 countries namely Afghanistan, Ghana, Nepal, Mauritius, Suriname, Nicaragua, Bhutan, Mozambique, the Solomon Islands, Sri Lanka, Nauru, Malawi, Guyana and Fiji. These countries have already adopted Indian Pharmacopoeia as their official book of standards.

“These new and updated monographs will be featured in the upcoming 2026 edition of Indian Pharmacopoeia to be released shortly. This development is vital for ensuring that every medicine manufactured in India meets a high standard of quality and safety," said the second official.

Experts underline the need for updated standards.

Dr Soumya Swaminathan, former World Health Organization chief scientist, said:“We definitely need updated standards for drugs. While central agencies have strong regulatory capacity, state-level variability is a key reason for substandard drugs in India. There is the need for consistent implementation of the same high standards across all states to ensure safety for both domestic and international markets."

According to the government document reviewed by Mint, efforts are on to secure international recognition for Indian Pharmacopoeia.“To achieve wider global acceptance, the Indian Pharmacopoeia Commission is working to harmonize its standards with international requirements," the document stated.

“The IPC is actively working to harmonize its standards with the Pharmacopoeial Discussion Group, which includes the US, Japan and the EU. This effort follows India's recent inclusion in the group in 2023. This harmonization will bring uniformity to Indian standards, further solidifying India's reputation as a leader in the global pharmaceutical market and making it easier for Indian drugs to be accepted worldwide," explained the third official.

The development of these monographs is of immense importance to public health, as they ensure that medicines are both effective and safe. They provide clear, scientifically backed guidelines that prevent the circulation of substandard drugs.

Harshad Lalwani, founder of Hummsa Biotech, views IP monographs as a common language for quality that significantly de-risks the company's operations. This includes qualifying methods, purchasing reference standards and enhanced impurity testing.

“While there's a modest, ongoing cost for surveillance, this investment is far outweighed by the benefits. Ultimately, these standards lead to fewer deviations, less re-testing, and smoother conversations with regulators, making it a cost-effective way to scale with global harmonization in mind," Lalwani said.

Viranchi Shah, national spokesperson for the Indian Drug Manufacturers Association, explained that these standards act as a counterbalancing regulation, ensuring products meet quality specifications. Shah stated that all companies selling in India must adhere to these norms, which directly dictate the quality of medicines available to the public.

“While many countries recognize US, British, and EU standards, the IP's standards are also accepted internationally, ensuring quality for both domestic and export markets," said Shah.

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