By Mr. Sudarshan Jain, Secretary General, IPA and Ms. Archana Jatkar, Associate Secretary General, IPA
The Covid-19 pandemic has catapulted the world into a humanitarian crisis of immense magnitude. It has presented an unprecedented challenge to public health, with healthcare being fundamental. The coronavirus spread rapidly through China and around the world with the WHO declaring COVID-19 a global pandemic in March 2020. As the world took emergency measures to address the crisis, the pandemic has had a profound impact on life and businesses across the world leading to lockdowns in many countries, restrictions on movement, travel, social gatherings, among others. In these unprecedented times, the Indian pharmaceutical industry emerged as a dependable partner by supplying uninterruptedly the life-saving medicines not only in India but across the world and demonstrated tremendous commitment towards patient welfare.
The COVID-19 Challenge
While the pandemic posed several new challenges, it also provided the pharma industry an opportunity to emerge as a reliable supplier of high-quality, affordable medicines. At the same time, this has been a period of significant learning for the Indian industry. When a national lockdown was announced in early 2020, the government, pharmaceutical associations and industry leaders in India worked in a coordinated manner to address the potential challenges.
Collaboration is Key
After the first week of the first lockdown in March 2020, manufacturing capacity across plants dropped to less than 20% due to various disruptions including the exodus of workers returning to their villages, shutting down of ancillary and related operations, prevention of workers from being able to reach their places of work and large-scale supply disruptions from China. In these trying times, supply of medicines is fundamental need of the hour for which smooth functioning of manufacturing operations is critical. This was recognised early on by the industry and the government. As a result, the Government of India classified pharmaceutical manufacturing, distribution, ancillary and support operations as essential goods and services and exempted it from lockdown. Effective collaboration among the government, pharma industry, trade associations, ancillary industry and others, enabled capacity utilisation to reach 70-80 percent by end of May 2020. Regular feedback, integrated efforts, sharing and consistent dialogue between industry stakeholders and government authorities has worked well during COVID 19 pandemic.
Need for Resilience in Supply Chains
The Active Pharmaceutical Ingredient (API)/Key Starting Material (KSM) supply disruptions from China in February 2020, had highlighted the dependence of the Indian pharma industry on imports. Given this, the Indian pharmaceutical industry needed to secure its supply of APIs and KSMs in the wake of the Coronavirus. The Government of India recognized the need to revive the domestic API manufacturing industry and announced an API policy incentivizing the domestic production of APIs/KSMs in March 2020. The core focus of creating scale and long-term survivability of the industry was developed through constant engagements between the API and formulation manufacturers and the Government.
Importantly, no drug shortages were reported domestically, and Indian pharma companies were able to meet global demand as well. The lockdown highlighted the importance of a diverse and resilient supply chain and the potential challenges of heavy reliance on one country for APIs.
Best Practices Protocols
In the initial period of lockdown/pandemic, the pharma companies worked onto share the best practices for the safety of employees engaged in the manufacturing of pharmaceutical products. Safety protocol documents were prepared and provided a comprehensive set of practices that have been deployed across pharmaceutical manufacturing companies in response to the COVID-19 crisis. The Indian companies came together to prepare a protocol for pharmaceutical manufacturing facilities in India in case any personnel is reported COVID positive. The objective of preparing this protocol was three-pronged –
The protocols were also shared with Indian Government authorities including the Indian Council of Medical Research (ICMR). The ICMR found the protocol useful and endorsed it. The sharing of protocol along with other safety measures taken by companies helped in strengthening the implementation of the safety measures underlining the importance of safety.
Vaccines and Re purpose Medicines
The disruptive role of the COVID-19 pandemic on the pharmaceutical industry has been varied and has challenged the industry to deliver solutions at a pace and efficiency. The industry responded promptly by evaluating possible utilisation of available drugs (repurpose drugs) and exploring more innovative approaches. Indian companies are engaged in developing indigenous vaccines that are currently undergoing testing for efficacy & safety. The momentum gained in R&D in India is positive and should continue beyond the pandemic. Innovation will act as a key catalyst in Indian pharma realising its Vision 2030.
The Way Forward
Indian pharmaceutical industry has been playing a key role in improving access to affordable medicines in India and abroad. As the race for a vaccine intensifies, the role of Indian pharma industry will increasingly become vital. This is an opportune time to move beyond firefighting and to address challenges facing the industry from a long-term perspective across the value chain. The need is to resolve bottlenecks and bring in simplified regulatory system that will boost competition, keep the quality enhanced and a market that fosters innovations.
In crisis lies an opportunity for India, to be truly the “Pharmacy of the World” and to realise its aspiration of reaching 120-130 Bn USD, becoming the largest volume producer in the world. Robust policy changes and additions implemented during the last nine months enabled pharmaceutical companies in the country to maintain production and increase efforts during the peak months of the pandemic. In the post-pandemic world, these collaborations with significant investments in R&D and innovations will define the course of our future.