Envisioning IDMA’S Role In Pharmaceutical Innovation: Dr Viranchi Shah, Indian Drug Manufacturers Association

IDMA engages with all important stakeholders at various levels. Within India, we constructively and actively engage with the government, regulators, policymakers, academic institutes, research organisations, and patient advocacy groups shared Dr Viranchi Shah, National President of Indian Drug Manufacturers Association in an exclusive interaction with Kaanchi Chawla of Elets News Network (ENN). Edited excerpts:

In the ever-evolving landscape of the pharmaceutical sector, how do you envision IDMA’s role in fostering innovation and competitiveness among Indian drug manufacturers?

IDMA is, probably, the world’s largest association of pharmaceutical manufacturers. Spread across India, we represent the voice of the Indian Pharma. IDMA members include those from small, medium, and large-scale sectors, and play a constructive role in upholding India’s name as the world’s pharmacy. India today proudly stands as the third largest manufacturer of pharmaceuticals globally. Almost every country on the globe procures essential medicines from India. A survey concluded that almost 20 per cent of the global volumes of off-patented medicines are manufactured in India. Being a significant global player, compliance and competitiveness underscore our vision and efforts.

Indian Pharma is focused on compliance & competitiveness, further keeping patient safety and product efficacy at center. Going forward, IDMA members see a great opportunity for the Indian Pharma industry to scale up from the current USD 50 billion industry to USD 500 billion during the Amrit Kaal. However, we perceive that this transformation can be fueled by shifting our focus from volume leadership to value leadership.

Innovation is a key ingredient for this transformation. When I took over as the National President of IDMA, we focused on RITE- Regulatory reforms, Innovation, Team building, and Entrepreneurship. Under this initiative, we have commenced a focused working committee specific to fostering innovation and research, for the IDMA members. IDMA is helping its members start thinking about innovation as an important growth strategy.

With the increasing focus on global regulatory standards, how does IDMA ensure that Indian drug manufacturers comply with international quality and safety requirements?

India being a significant global pharma player, IDMA is aware of its members’ responsibilities towards patients. A large number of our members have global GMP certifications, including the most stringent certifications such as US FDA, EU GMP, and PIC/s. Most of our members are already compliant with WHO GMP standards. IDMA has a focused task force to work on quality and safety. We have a regulatory affairs committee engaged in promoting the latest regulatory compliances among the members.

We also have a technical committee working towards the technical compliance. We have 22 different committees that handle various areas important for Indian pharma to excel. These focused groups help and encourage our members to comply with international quality and safety standards. We undertake training programs and arrange seminars to help our members. APPQM is a flagship program of IDMA that has crafts quality change agents for the industry.

Our experts are on committees that make key policies. These include those related to the D&C Act, PRIP, PLI, IPC, and SPI to name a few. IDMA was a part of government consultation for strengthening the pharma industry especially the SMEs through the SPI scheme. We complement the government, and especially the Ministry of Health and Family Welfare as well as the Department of Pharmaceuticals under the Ministry of Chemicals and Fertilizers, for bringing some important schemes that focus on strengthening the SMEs in India. We also compliment the DCGI, CDSCO, and all the State regulators for their hand-holding in helping the industry focus on compliance in safety and quality.

Collaboration between industry stakeholders is crucial for growth. How do you facilitate partnerships and alliances between Indian drug manufacturers and other global players?

IDMA engages with all important stakeholders at various levels. Within India, we constructively and actively engage with the government, regulators, policymakers, academic institutes, research organisations, and patient advocacy groups. We work shoulder to-shoulder with other associations like IPA, OPPI, BDMA, and FOPE. IPA is a strong supporter of IDMA and its activities.

IDMA engages with IPA on key policy issues and takes help and support in building IDMA members’ capabilities. We thank IPA for their generous support. IDMA also engages with BDMA on all issues related to the API industry. We have MOUs with several global organisations, for example, the Korean industry association, the Sri Lanka industry associations, etc to name a few. Over and above this, we interact and engage with several global associations, regulators, and stakeholders.

India’s pharmaceutical exports play a significant role in the global market. What strategies do you adopt to support Indian companies in expanding their reach and penetration in international markets?

IDMA has a dedicated committee to facilitate exports. The president of IDMA is an ex-officio CoA member of the Pharmexcil- the council entrusted with the task of facilitating exports. IDMA believes that India has a very strong case for expanding its global reach owing to the Industry’s inherent strengths like quality & affordability.

The new areas of focus such as the revival of the domestic API industry will further strengthen the competitiveness of the formulation industry. Another key area – innovation, leads to our quest for value-added products; this too will further enhance our global success. The rise of the Indian devices and medtech industry, innovations in drug-device areas, and progress in the wearable and diagnostics industry in India are some developments that will further strengthen the brand of India and contribute to the growth of the Indian pharma sector. These are part of the array of offerings that India can present to the global healthcare industry.

We have been helping our members to strengthen their growth both within India and internationally. Vriddhi is a very significant IDMA initiative that aims to foster entrepreneurship. Through this, we help our members to broaden their thought process, expand their vision, and help them execute their ideas so that they can scale up globally.

In light of emerging trends like personalised medicine and biopharmaceuticals, what steps are your organisation taking to empower Indian drug manufacturers to seize new opportunities in these areas?

Biopharmaceuticals and personalised medicines are very important trends emerging globally. We compliment the government for focusing on these areas while framing policies such as PRIP, PLI1, and PLI2. Our members are already working in this domain, and we hope that going forward these technologies will come to mainstream in India. We must understand that currently these technologies, as well as some therapies in this domain, are very expensive and out of reach of most people in low and middle-income countries. As IDMA, we aspire that Indian Pharma will focus on the development and commercialisation of biosimilar products and personalised medicines, and try to make them affordable and available for large masses.

How does IDMA encourage a culture of ethical business practices and compliance within the pharmaceutical industry, ensuring transparency and accountability in all operations?

IDMA members are committed to ethical business practices. We have a code of conduct for our members. We also have an Ethics Committee and an Apex Committee to enforce the Uniform Code of Pharmaceutical Marketing Practices. We encourage our members to adopt ethical practices. We also engage with regulators, patient advocacy groups, media, and other stakeholders, and take their inputs for constant improvements. IDMA and the Indian Pharmaceutical industry, have focused on providing good quality affordable medicines to the world, and we shall continue our efforts in the years to come. A survey has indicated that in the last 20 years, the global life expectance has increased by almost 6+ years. The Indian pharmaceutical industry has an immense contribution to improving the global life expectance as well as improving the quality of life of people across the globe. We shall continue our endeavor to contribute to the society by our sincere efforts.

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