Impact of COVID-19 on pharma formulation: Bhupendra Pratap Singh Chauhan, CQA Head, Morepen Laboratories

Bhupendra Pratap Singh Chauhan, CQA Head, Morepen Laboratories, started his address by sharing some facts and figures with the audience. Quoting data from the Ministry of Commerce, he stated that India’s pharma exports touched Rs 1.8 trillion in fiscal 2022, marking flat growth compared to the last fiscal. In the pandemic year of 2020-21, pharma exports had grown by 18 per cent to $24.4 billion (roughly Rs 1.8 lakh crore at current exchange rates), he noted. Apart from it, he also informed that pharma export from India was $20.7 billion in financial year 2020 as compared to $19.14 billion in 2019.

Additionally, according to the Indian Economic Survey 2021, the domestic market is expected to grow three times in the next decade. India’s domestic pharma market is at $42 billion in 2021, and is likely to reach $65 billion by 2024 and further expand to reach ~$120-130 billion by 2030, Chauhan informed.

He also highlighted that the COVID-19 pandemic has changed an era. While there was a termination or postponement of a large part of clinical trials for various indications, new guidelines for conducting the trials were introduced by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). The pandemic caused failure in the global supply chain and lack of active substances and basic and life-saving drugs, which then led to a focus on creating an efficient supply chain and positive opportunities for risk management.

Moreover, since there was an increased application of conditional marketing authorisation for COVID-19 vaccines and reorganisation of the therapeutic application of medicines without a patent, clinical trials were conducted to evaluate the efficacy of a number of medicinal products, he mentioned.

India can aim to further strengthen its position by garnering a larger share in world pharma trade by manufacturing value-added products, he concluded.