As per Indian Pharmaceutical Alliance (IPA), the pharma industry demonstrated tremendous reliability during the pandemic despite challenges in the supply chain and changes in the consumption pattern of drugs.  The companies quickly adopted safety measures including guidelines for pharmaceutical employees, the protocol to handle positive COVID-19 cases in manufacturing facilities - endorsed by the Indian Council of Medical Research (ICMR), and guidelines on containment of the spread of COVID-19 from the Health Ministry.

When asked about the learning points during COVID-19, Sudarshan Jain, Secretary-General, IPA quickly lists out quality and quick innovation on the top followed by flexibility in operations, dealing with supply unpredictability, digital interventions among others.  There has been a growth in internal and international collaborations during the pandemic, adds Jain while speaking to Indian Chemical News virtually on the sidelines of the Editors’ Round Table meet for the 6th India Pharmaceutical Forum (IPF) 2021.

Underlining the Indian pharma industry’s response to COVID-19, Jain says it ensured the global availability of medicines. “Industry has adhered to employee safety protocols; resolved on-ground challenges by establishing engagement with government and facilitated coordination with associations around the world.”

Shirish Belapure, Senior Technical Advisor, IPA seconds him. Listing the fast response from regulators and their 24*7 availability as quite extraordinary, he says the pandemic has prepared the industry well to deal with any future eventuality. “Shortest time to market, collaborations, and demand predictability are the other things taught by it.”

Since the fast track regulatory approvals during pandemic became a norm, does it mean a revival of the clinical research industry in India?  Vikas Bhadoria, Senior Partner, McKinsey India says it is not an easy journey unless there are clear regulatory laws and enough industry-academia collaborations. He says, “With a focus on faster approvals for COVID vaccines and diagnostics during the pandemic, MNCs are now looking at more trials happening in India. In the next 3-4 years, one can only expect a better clinical research ecosystem.”

Road to recovery

The Indian pharma industry contributes to 40% of all drugs consumed in the US. In 2019, 395 Indian ANDA’s were approved in the US and it also stands at the first position in the number of USFDA approved plants outside of the US. Globally, it has the third-largest share of drugs volume-wise and contributes to 60% of global vaccine production.

Going forward, the industry’s recovery roadmap addresses three areas: manufacturing,; transportation & logistics; and ancillary industry associations. In this direction, IPA is focusing on five key areas.

First is building thought leadership by sharing best practices with the industry. Its best practices documents released in 2020 addressed analytical method development, product robustness and handling of market complaints.

The second area of focus is capacity-building through various forums convened throughout the year. It conducted the 5th AGMP Workshop related to the latest advancements in manufacturing technology and quality. It also organized 6th IPF 2021, a flagship event of the IPA Quality Forum – discussions central to achieving Quality excellence. It is also conducting monthly webinars as a knowledge development and dissemination platform to discuss best practices in manufacturing and quality.

The third focus is engagement with regulatory agencies such as USFDA and other international regulatory agencies. It also plans to hold quarterly and half-yearly meetings with USFDA India Office for better communication. It is also looking at increased collaboration with international regulatory agencies like MHRA, EMA, EDQM, and Indian regulators like Central Drugs Standard Control Organization (CDSCO) with whom it is closely working on 3 levels: capability building sessions across the country (advanced GMP); workshops like ‘Recent Amendments in Drugs & Cosmetics Rules for Effective Implementation’ held in Assam and quarterly discussions for greater collaboration going forward.

Another top focus of IPA is the collaboration with other industry associations and academia by driving active engagements. It is looking at collaborating with WHO and JSS for piloting the training program on cGMP for pharma units. With IGBA and AAM, the collaboration is for industry positions on Nitrosamine impurities, virtual inspections, recommendations on improving regulatory flexibility. With PDA and USP, it collaborates through seminars, conferences, and knowledge-sharing sessions.

Additionally, IPA is closely working with the Pharmacy Council of India on course curriculum and syllabus up-gradation of the B Pharm and M Pharm courses to meet the latest industry expectations. It is also looking at developing a program to train the faculty of pharmacy colleges on the latest technological advancements to enhance faculty’s practical experience.

The leading association is also looking a creating standardized view of performance across Indian Pharma companies. It wants the Indian companies to apply the latest manufacturing and testing technology and integrated digital analytics and automation deployment. The focus is on a strong pool of digital and technology talent (specialized personnel) to drive the above sustainably, across companies. The strong focus on quality and compliance also remains high on the agenda.