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The Indian excipient industry is steering towards harmonisation of standards and supply chain security. The industry also needs to focus on research to widen its scope to develop quality products and processes in production. The sector has not seen the kind of investments like that of generics and API because of paucity of investors and incentives. This, according to the International Pharmaceutical Excipients Council of India (IPEC-India), is the key factor that hinders the growth of this industry in the country.
According to Ravleen Singh Khurana, CEO, Nikita Pharma, a key reason for this is that not many companies are engaged in excipient research. The industry is capital intensive, the margins are not high and hence the focus has been on volumes only. These factors perhaps could deter the future growth of the sector.
When India has positioned itself as the largest exporter of formulations, excipients account for a miniscule share which is a mere one percent to the global market. Under the Atma Nirbhar programme, the domestic excipient industry needs to take on the challenge, Khurana added.
According to the IPEC-India, the excipient sector has not received the required attention because it has not caught the eyeball of investors. “We also need to encourage all our pharmacy colleges to focus on topics like excipient research and manufacture by students during their research projects. There is also need to include a dedicated subject on excipients in the pharmacy curriculum,” according to the IPEC-India.
Here Khurana added, “This would create the required quality workforce for the excipient industry which is known for its sophisticated technology including application labs.”
At a webinar on ‘Excipients: Mitigation of Supply Chain, Quality & Regulatory Challenges’ which was moderated by Subodh Priolkar, CEO, Wincoat Colours & Coating and vice-chairman IPEC India, the discussion revolved around the need for mandatory IP compliance, GMP adherence and supply chain issues.
Vishakha Metkar, sr manager, regulatory, Colorcon Asia and chairman regulatory committee IPEC-India, said that not much headway has been made in the harmonisation of IP monographs with other pharmacopoeias. “IPEC India is working on reviewing of the IP monographs for excipients to bring it in line with the global standards.”
Nilesh Gandhi, consultant and ex-assistant commissioner, Maharashtra FDA provided an overview on the regulatory framework for excipients. “Indian regulators are much more receptive to new ideas and initiatives which is a positive sign,” he said.
Since supply chain is a critical component for all industries including excipients, Kesava Menon, senior manager, materials, Colorcon said the pandemic's impact on the sector was severe. All the aspects of supply chain: ocean, air and road freight were hit during the global and national lockdown. The transport operators were unwilling to move without a substantial volume as it was not economically viable. Now, the situation is more or less stabilised.
In his introductory remarks Kaushik Desai, secretary general, IPEC-India said that one of the objectives of IPEC India is to support development of third party certification and extend advice on source of quality of excipients.
Pressing for better visibility of the Indian excipient sector, the panel also noted that government support for application labs for research is much-needed. The whole focus currently in the country is to become self-reliant in APIs and key starting materials (KSMs) by the government with not much attention given to excipients. India currently imports 10 lakh metric tons of excipients as against 1.20 lakh tons of exports, which can be reversed only with government support.
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