The Union Government has sought to quell concerns over an imminent shortage of active pharmaceutical ingredients (APIs) and medicines in the country due to the novel coronavirus (COVID-19) outbreak. However, individuals from the pharmaceutical sector are still disconcerted.
The outbreak has had a kn0ck-on effect on multiple industries in India. As well as pharma, chemicals, electronics and textiles have been affected. The root cause is Indian reliance on China – where the COVID-19 outbreak originated – for its inventory of APIs. Chinese imports account for between eighty and 85 percent of India’s API imports. In broader terms, China accounted for 67.56 percent of India’s Rs 25,552 crore worth of imports of “all bulk drugs and intermediates” in the 2017-18 fiscal year, according to The Hindu Business Line.
The outbreak sparked concerns among voices from the pharmaceutical industry. Pankaj R. Patel, chairman of Zydus Cadila, told Bloomberg in February that there could be a drug formulation shortage as early as April, sans a return to normalcy in the first week of March. Meanwhile, price increases have been seen for commonly-used products such as the analgesic paracetamol.
However, the Government has sought to assuage fears and maintains that India’s inventory of APIs is healthy and sufficient. “There is no shortage of any APIs in the country,” asserted D. V. Sadananda Gowda, Union Minister of Chemicals and Fertilisers whilst inaugurating the India Pharma and Medical Devices 2020 Conference in Gandhi Nagar, Gujarat. He affirmed that “we have sufficient APIs and medicines in the country…for another three months there is no shortage for undertaking production in the pharma sector.”
Minister of State Mansukh Mandaviya also addressed the Conference, expressing the need for India to reduce its import dependency for APIs. “We have discussed in detail to ensure that we are able to sustain in the international markets regarding the APIs and we are shortly coming out with two policies,” he said. “The benefit of these schemes will be for the API parks and medical drug parks. India will become self-sustained in APIs.” To this end, he said “a task force has also been set up regarding APIs and I am leading it. We have decided to increase the production of APIs in the country so that we are not dependent on any country for them.”
Despite assurances, Indian pharma is still concerned about the future. “If the low imports continue for another month or two, then there can be an impact,” cautioned Viranchi Shah, chairman of the Gujarat chapter of the Indian Drug Manufacturers’ Association (IDMA). However, Shah did state that “there is no immediate short-term impact.”
Concerns over the impact of COVID-19 on Indian pharma is palpable overseas. India, Shah said, “is the pharmacy of the world. We provide medicines…to around 200 countries.” Yet following a decision to ban exports of 26 APIs and drugs that account for ten percent of its total exports, international markets are alarmed. Dinesh Dua, chairman of the Pharmaceuticals Export Promotion Council of India, reported that he was “getting a huge number of calls from Europe because it is very sizeably dependent on Indian formulations and we control almost 26 percent of the European formulations in the generic space.”
In the United States, Indian imports accounted for 38 percent of pharmaceutical ingredients as well as almost 25 percent of medicines in 2018. Food and Drug Administration Commissioner Stephen Hahn has informed lawmakers that the U.S. government is taking stock of the situation to assess whether it will affect supply chains.
The World Health Organization (WHO) is also apprised of the situation. “At the moment it’s not as restrictive as we see right now with personal protective equipment,” commented Paul Molinaro, who is chief of operations support and logistics at the WHO. However, he added, “the fear is that the ripple effects will make shortages in those medicines as well.”