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IPC releases ninth edition of Indian Pharmacopoeia

Four countries – Afghanistan, Ghana, Nepal and Mauritius- have accepted IP as a book of standards

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The Indian Pharmacopoeia Commission (IPC) launched the ninth edition of the Indian Pharmacopoeia in Delhi last month in the presence of Dr Mansukh Mandaviya, Union Health Minister, Dr Bharti Pravin Pawar, Union Minister of State and Dr Rajesh Bhushan, Health Secretary, Government of India. The theme of this year’s conference was ‘Addressing Medicine Quality for Future.’

Speaking on the occasion, Dr Mandaviya, said, “We have become “pharmacy of the world” by specialising in generic medicine formulation and manufacturing, and by supplying affordable medicine to the world. But we still need to strengthen research in pharmaceuticals sector. Four countries – Afghanistan, Ghana, Nepal and Mauritius- have accepted IP as a book of standards. We should make a roadmap and move forward so that more countries accept our pharmacopoeia.”

Further, highlighting the role of the government, he said, “As a result of the vision of our Prime Minister Narendra Modi ji and our work in that direction, the world has started recognising us and giving importance to our work and accepting it. We should focus on how our pharmacopoeia can take advantage of this focussing on international trade and industries based on our strength in indigenous medicines. Pharmacopoeia is important to develop a Swasthya and Samrudh Bharat, to maintain standard quality of our medical products- vaccines, medicines, equipment, etc. and to keep an eye on the effect of these medicines on patients.”

Pointing out that India is the world’s largest supplier of generic medication and accounts for 20 per cent of the worldwide supply of generics by volume, he further said that during COVID pandemic, India has delivered accessible and affordable vaccines to 150 countries.

“While delivering vaccines and other generic medicines to so many countries, we have never compromised with the quality and standards or delivered substandard or spurious drugs. India has earned global accolades as a result of this,” he added.

Rajesh Bhushan, Health Secretary, Government of India, said, “The two years of handling the pandemic has made us realise that while in this country, as another country, we were grappling with the challenges of communicable and non-communicable diseases, we should always be prepared for pandemics, which may, in future, come with alarming regularity, and that is a serious thought to reflect on……The pandemic made us realise that you need to repurpose some of the options without losing time. You need to innovate and ensure that from R&D, to innovation to a product, to its regulatory approval and delivery in the market, needs to be compressed in a time frame.”

IP 2022 contains a total of 92 new monographs, including 60 chemical, 21 vitamins, minerals, amino acids, fatty acids, etc., three biotechnology-derived therapeutic products, four human vaccines, two blood and blood-related products, two herbs and herbal-related products, and seven phytopharmaceutical ingredient category monographs. This has led to the total number of 3,152 monographs in the current edition of IP. In addition, 12 new general chapters have also been introduced. Several monographs and general chapters have also been revised to update them as per current global requirements and to harmonise with other pharmacopoeias like USP, BP, EP, etc. The harmonisation of standards with global standards is expected to help IP getting recognised and accepted in foreign countries.

Dr Rajiv Singh Raghuvanshi, Secretary-cum-Scientific Director, IPC, notified that the team is in the process of developing digital IP. He also informed that a new category “Controlling the quality of raw materials” has been created in IP 2022. Apart from it, IPC is not thinking of creating monographs for the end product, but the raw material.

Speaking about the “Indian pharma growth: Facilitating regulations and quality expectations,” Dr Saranjit Singh, Ex-professor, Pharmaceutical Analysis, NIPER, Mohali, expressed his concern regarding One Drug, One Quality, One IP. He asked if implementing such a concept is practical.

He also said that India has the best talent pool. “The manpower is changing the US monographs one after the other,” he emphasised.

Regarding facilitating regulations and quality expectations, he stressed that there has to be a coordination between IPC setting standards and regulators because they get a lot of data that is used for framing regulations or policies.

After Dr Singh’s address, James Pound, Secretary and Scientific Director, British Pharmacopoeia Commission (BPC), spoke about the role of standards in medicines quality, which includes patients’ safe and efficacious treatment, acceptable medicines quality, GxP, public quality standards and regulatory assessment.

He also informed about BPC’s international collaborations with the Ukranian Scientific Pharmacopoeial Center for Quality of Medicines, IPC, US Pharmacopoeia, World Health Organization (WHO), Council of Europe, Pharmaceuticals and Medical Devices Agency (PMDA), Farmacopeia Brasileira and European Directorate for the Quality of Medicines and Healthcare (EDQM).

Sharing his views with the audience on Indian Pharmacopoeia, Dr VG Somani, Drugs Controller General of India (DCGI), said, “India’s greatest discovery is our Indian Pharmacopoeia. Had IP had not been there, one would not have been able to get the IP book at a peanut cost.”

He also informed about the collaboration between CDSCO and IPC for development of standards, monographs of drugs, including biologicals, general chapters and guidance documents, obtaining raw materials for preparing reference standards, etc.

The collaboration is also for Pharmacovigilance Programme of India (PvPI) for drugs and Materiovigilance programme for medical devices and for promoting the use of IP. He further notified that CDSCO is member of IPC Governing Body, Steering Committee and Signal Review Panel.

He also shed light on the key regulatory activities conducted by CDSCO in tackling the pandemic. These include expedited evaluation of CT protocols, sites and testing; accelerated approval process in accordance with NDCTR 2019; publication of notification for stockpiling of vaccines under clinical trial as well as door step delivery; regular participation in various international regulatory platforms like ICMRA, WHO, R&D Blue Print and RVAG with international regulatory agencies to ensure regulatory agility and decision making to cope with the pandemic outbreak, among others.

Dr Somani also spoke about the international collaborations of CDSCO with various countries. “CDSCO has signed MoUs with 11 regulatory authorities of countries like the US, the UK, Japan, Russia, etc. MoUs with regulatory authorities of more than 30 countries are under process (eg China, Mexico, Canada, Germany, etc).”

Apart from it, active interactions are related to medical device cooperation with Global Harmonization Working Party (GHWP), Asian Harmonization Working Party (AHWP), Asia Pacific Medical Technology Association (APAC Med), IMDRF and WHO.

Dr Viranchi Shah, National President, Indian Drug Manufacturers’ Association (IDMA); Director, Saga Labs, expressed his views on the future India: Vision 2047, which includes making India $130 billion industry by 2030, $500 billion plus by 2047, and having at least one in top 10 global pharma companies, at least one in top 10 global pharmacy colleges, increased access to technology and increase in household incomes, among others.

Looking forward, Dr Shah suggested that IDMA can contribute/support to provide reliable source of candidate materials for the preparation of IPRS and impurities. It can also contribute on various technical committees of the IPC. He also put forward consideration to include at least 25 FDCs (by volume in the Indian market) in IP, which would enhance the confidence between manufacturers and regulatory mechanism.

Later, Dr BM Rao, Head, QA, Emerging Markets, CQC and ASAT, Dr Reddy’s Laboratories, spoke about ensuring product quality at MSMEs. To ensure minimum quality standards, he suggested a six-system quality model that includes production system, facilities and equipment system, laboratory system, materials system, and packaging and labelling system.

He also talked about the expectations, challenges and mitigation plans associated with facilities and utilities, equipment, material management, production system, packaging and labelling, laboratory control and data integrity.

Lastly, a panel discussion took place wherein the panellists, A K Pradhan, Joint Drugs Controller; Dr Hemant Koshia, Commissioner, Food and Drug Administration, Gujarat CDSCO; Dr Raghuvanshi and Dr Singh discussed India’s strengths as the pharmacy of the world and the things that could hold it back.

Focus on quality and affordability of drugs, adopting international practices and making those Indianised, focus on innovation and R&D, strong regulation system, minimum investment for starting a industry, good talent pool of technical people, and a proposal for the Centre’s Research Linked Incentive (RLI) scheme, among others, were highlighted as some of the strengths of the Indian pharma industry by the panellists.

A few suggestions for making the industry better included bringing in science and technology in every process that is conducted, successful implementation of IP in structured manner and bringing better predictability in the regulatory system.

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