India’s ban on Covid-19 vaccine exports is likely to last until October, sources say, while pandemic disruption in India is hurting the global supply chain for many other medicines. During the country’s deadly second wave in March, the Indian government stopped vaccine exports and opted to inoculate the Indian population instead. India is the largest manufacturer of Covid-19 vaccines globally, with Serum Institute of India (Maharashtra, India) expected—until now—to produce a third of this year’s global supply of AstraZeneca’s (Cambridge, UK) Vaxzevria vaccine.
The export ban was extended in May, and government sources have said that India is unlikely to resume major exports of Covid-19 vaccines until at least October as it diverts shots for domestic use. The Serum Institute said that it hoped to restart deliveries to the Covid-19 Vaccines Global Access (COVAX) initiative and to other countries by the end of this year.
As of 11 June, only 3.3% of India’s population has been fully vaccinated (equating to almost 46 million citizens), according to Indian government statistics. The World Health Organisation’s (WHO) chief scientist said that the export ban had affected 91 countries by 1 June, and that AstraZeneca has “not been able to compensate for the doses that have not come from Serum [Insitute of India].”
Pharma production sites affected
India is experiencing the worst Covid-19 surge worldwide to date. Its second wave, which started in February, was triggered by the significantly more infectious Delta variant and has caused significant loss of life and disruption to business. The situation became desperate this year as hospitals ran out of beds, oxygen and medication to treat an ever-growing number of Covid-19 patients caused by the Delta variant. India manufactures many drugs for export to the US, Europe and other markets, and therefore significant supply chain disruption may take place as a result of this second wave.
Of all Indian states, Maharashtra has the highest number of drug contract manufacturing sites for innovator drugs (353) and is also the worst hit by Covid-19, with almost six million confirmed cases as of 15 June. The majority of Maharashtra’s facilities offer small molecule active pharmaceutical ingredient (API) manufacturing, with 21% offering solid dose manufacturing (EMOR, September 2018). Lockdown measures in Maharashtra have caused supply chain problems, with local government guidelines demanding that truck drivers entering the state must have proof of a negative reverse transcription-polymerase chain reaction (RTPCR) test issued within the past 48 hours.
The state second most affected by Covid-19, Karnataka, has 93 contract manufacturing facilities. Karnataka has one of India’s fastest-growing pharmaceutical sectors, with around 40% of the state’s pharma production being exported overseas. The state is an emerging pharma powerhouse, particularly its city of Bangalore, and its success is largely driven by its biologics production (EMOR, September 2020).
Most facilities in Andhra Pradesh are owned by domestic Indian pharmaceutical companies and offer small molecule API manufacturing (EMOR, September 2019). Kerala is a large state but has a very underrepresented pharma industry, partly due to its left-wing government not being able to attract businesses (EMOR, September 2020).
Lockdown measures have disrupted supply chains for an already overburdened Indian logistics sector, with transport delays commonplace as truck drivers are reluctant to travel during a time of rising cases and curfews. The pandemic and resulting lockdown measures are affecting freight networks, causing labour shortages, and have raised the price of raw materials by reducing and delaying their supply.
Four cities, namely Hyderabad, Mumbai, Visakhapatnam and Ahmedabad, and one town, Badi, collectively account for 28% of all Indian pharma contract manufacturing sites. Hyderabad, located in the state of Telangana, has the most facilities, but it is one of the states least affected by Covid. However, Mumbai is located in the worst affected state, Maharashtra. Visakhapatnam is a port city and industrial centre in the state of Andhra Pradesh, the fifth worst Covid-affected state. Ahmedabad, in Western India, is the largest and most populous city in Gujarat and the eleventh worst affected state. Badi is a town in the state of Madhya Pradesh, which has slightly fewer confirmed cases than Gujarat.
Covid vaccine and drug supply disruption
Indian manufacturing is vital to the global vaccine drive, which aims to end the pandemic. AstraZeneca’s Vaxzevria vaccine is manufactured at Serum Institute of India’s (Maharashtra, India) site in Pune, Maharashtra, while Johnson and Johnson’s (New Brunswick, New Jersey) Covid-19 vaccine is manufactured at Biological E’s (Hyderabad, India) site in Himachal Pradesh, India. Several Indian contract manufacturing organisations (CMOs) produce the Gamaleya Federal Research Centre of Epidemiology and Microbiology’s (Moscow, Russia) Sputnik V vaccine.
The manufacture of these vaccines takes place across multiple sites worldwide, so problems in a single country will not halt production altogether. They will no doubt, however, affect scale and timelines, which are critical when attempting to vaccinate the entire global population. Many of the additional sites for AstraZeneca and J&J’s vaccines are in developed markets, so India’s export ban will cause less disruption there than it will in Africa and China.
Serum Institute of India has had difficulty obtaining enough raw materials for vaccine production. In March, it sought the Indian government’s intervention in helping import raw materials from the US, and in April, the company publicly called for the US to lift its embargo on raw material exports. In May, Adar Poonawalla, the CEO of Serum Institute of India, fled the country for London, stating that “powerful Indians” were threatening him for access to doses.
As Figure 2 shows, at least 65 biosimilar and innovator drugs are known to have their APIs manufactured at Indian sites. Significantly fewer have their dose manufactured or packaged at Indian facilities, specifically 44 and 27 products respectively. These figures include only drugs approved in the US, UK (post-Brexit) and/or EU and rely on publicly disclosed contract service agreements, so total numbers will be higher. India is long established as a prime location for API small molecule production.