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Business Standard
16-06-2025
- Health
- Business Standard
70% vaccines sourced by WHO are from India; US imports 14% generics
Union Minister of State for Health Anupriya Patel said on Monday 70 per cent of total vaccines sourced by the World Health Organization (WHO) and 14 per cent of generics imported by the US are from India. She delivered the keynote address at the inaugural session of the Second Policymakers' Forum organised by the Indian Pharmacopoeia Commission (IPC) here. An international delegation of policymakers and drug regulators from 24 countries is participating in the forum. Aimed at promoting the recognition of the Indian Pharmacopoeia and collaboration in India's initiative for flagship affordable medicines -- the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) -- the Forum is being organised by the IPC under the aegis of the Ministry of Health and Family Welfare in association with the Ministry of External Affairs. In her keynote address, Patel emphasised India's commitment to ensuring equitable access to quality-assured medicines and stressed the importance of regulatory harmonisation in facilitating global health equity. She also highlighted that "under the visionary leadership of Prime Minister Shri Narendra Modi, India has emerged as a global hub for affordable healthcare solutions and continues to deepen its partnerships with nations through knowledge-sharing, capacity-building and health diplomacy". Underlining the importance of the Jan Aushadi Kendras, Patel said, "Our Jan Aushadhi Kendras are the shining examples of India's commitment to provide quality and affordable medicines to all our citizens. Jan Aushadhi has been one of the most powerful instruments of bringing down the out-of-pocket expenditure of our citizens." Highlighting India's strides made in the direction of providing vaccines, Patel said India continues to be a leading supplier of vaccines. "As much as 70 per cent of WHO's total vaccines are sourced from India," she said. She said during the COVID-19 pandemic, India started the 'Vaccine Maitri' initiative and supplied vaccines to more than 100 friendly countries, which depicts India's deep sense of responsibility towards global health and its intention of helping friendly countries in times of distress. Patel said, "India continues to be a leader in drug manufacturing, especially when it comes to generic medicines. 14 per cent of generics imported by the US come from India while India also has the maximum number of US FDA (Food and Drug Administration) recognized drug manufacturing plants." She further underlined that "70% of our generics are exported to the highly regulated markets and our pharmacopeial regulations are regularly visited to meet the global benchmarks". Patel said, "We have retained the WHO's Global Benchmarking Tool (GBT) framework, Maturity Level 3 (ML3) status which reflects the robustness of India's regulatory framework. Presently, 15 countries in the world recognise Indian Pharmacopeia as a book of standards for drugs, Cuba recently becoming the 15th country to recognise the Indian Pharmacopeia." She said it is not just a regulatory step but a move towards bringing more alignment in the quality standards, expanding access to safe and effective drugs and making trade in pharmaceuticals smoother than ever before. Patel reaffirmed that "we are committed to helping our partner countries by way of communicating and planning" and "hope to continue to work together to advance the regulatory collaboration and promote the recognition of the pharmacopeial standards so that we can strive fast towards the shared goal of 'Health for All'".
Indian Express
06-06-2025
- Health
- Indian Express
India has to maintain global regulatory standards to remain the pharmacy of the world: Ex DCGI
Former Drugs Controller General of India (DCGI) Dr G N Singh, who is now the Advisor to Uttar Pradesh Chief Minister Yogi Adityanath, was leading an outreach programme in Gujarat for pharmaceutical companies to set up units of the Bulk Drug Pharma Park coming up in Lalitpur district. He spoke to The Indian Express on the sidelines of the country's need to maintain global scientific standards and regulation. Dr Singh also served as the Central Drug Standards Control Organisation (CDSCO) for six years till 2018, and as the Founder-Director of the Indian Pharmacopeia Commission (IPC). Excerpts from the interview: How do you see the development and future of the pharmaceutical manufacturing sector in India? India wants to become self reliant in manufacturing and innovation in bulk drugs. That is why the Prime Minister, over the last few years, has given special emphasis on developing pharma parks across the country. In this context, the UP Chief Minister decided to develop a bulk drug park in his state. And we want to make sure that if any international incident happens, since the geopolitical situation is in a troublesome phase, then we can be self-reliant. In such cases, India has to be ready to address issues like healthcare. We (India) are known as the pharmacy of the world since we supply medicines to more than 200 countries. So we have to see that the continuity of supply of medicines remains undisturbed. When you talk about the geopolitical situation, are you referring to the excessive imports of Active Pharmaceutical Ingredients (APIs) from China? Majority of our APIs are being imported from China. It is the thinking of experts at the highest level that India has to be fully self-reliant. We are, but due to cost prohibition, we were lacking in API production. Now with bulk drug parks coming up, the cost of production will also come down and we will become competitive in the international market and hopefully begin supplying APIs to many others, especially Europe and other developed markets. We will capture those markets based on quality, prices and uninterrupted supply. There have been complaints coming in from many nations, including Africa and Europe and ones flagged by the USFDA, regarding the quality of drugs going out from India. How do you see this in context of the way 'made-in-India' medicines are perceived abroad? As scientific systems are developing, the regulatory landscape is also changing. We are continuously adjusting the regulatory system so that the regulator meets the expectations of scientific rigour and the people. Safety, efficacy and quality of medicines is of paramount importance to the regulator and to end users everywhere. So, we want to make a harmonised approach so none of the issues lag behind the science requirements. Both the Drugs and Cosmetics Rules and the Indian Pharmacopeia (IP), which is the book of standards for drugs, are continously being upgraded to address these issues. So, does the Indian drug regulator need more teeth? Is stricter regulation required today? The requirement is to strengthen the drug regulatory system in terms of science, in terms of manpower, in terms of the execution of mechanism and the government must be thinking on those lines because it is aware of these issues. If we want to remain the pharmacy of the world we need to maintain the standards of global science and regulation. The most recent debate is regarding generic drugs. There have been problems highlighted with regards to bioequivalence studies and doctors are pushing back against compulsorily prescribing them. How do you see this issue? It is only a myth. These issues have been raised multiple times and as a scientist, I am of the firm opinion that the book of standards is the same for branded, branded-generic or generic medication. If you take the Indian, US and UK Pharmacopeias, they are not ascribing different standards. They are all the same — right from manufacturing systems, quality control and testing before batches reach the market. So, I don't agree that generic drugs are in any way less than the branded medicines and it is just a myth with no basis in scientific parameters. They are almost equal in my opinion and I had made it very clear on various forums, including international ones, not just as a former drug regulator of this country, but also as the head of the Indian Pharmacopeia Commission. I appeal to the doctors and to the people to accept generic medicines as ones at par with the branded ones.
