HONG KONG – India’s Ministry of Health and Family Welfare (MOHFW) has drafted rules for the manufacturing, import and the compassionate use of unapproved drugs in the treatment of patients.

In a notification published in The Gazette of India on June 5, the MOFHW laid out the draft of certain rules to amend the New Drugs and Clinical Trials Rules, 2019. The draft would allow medical institutions and hospitals to use drugs undergoing phase III trials in India or in any other country “for treatment of patients suffering from life threatening disease or disease causing serious permanent disability or disease requiring therapy for unmet medical need.”

The draft also allows for the compassionate use import of a new drug undergoing clinical trials.

However, the quantity of any single drug imported shall not exceed 100 average dosages per patient. But there is leeway for “exceptional circumstances,” and the Central Licencing Authority may allow the import of new, yet-to-be-approved drugs in larger quantities depending on the condition and requirement of the patient.

The 100-average-dosages-per-patient limit also extends to the manufacturing of such experimental drugs by manufacturers in India.

The central government is considering all objections and suggestions that are received from any person or interested party by June 20.

The move is clearly inspired by India’s battle with the COVID-19 pandemic. In the next two weeks, India is expected be the fourth most heavily affected country in the world behind the U.S., Brazil and Russia, if the current trajectory of daily confirmed COVID-19 cases is anything to go by.

"Based on the historical data for new cases of COVID-19, India appears nowhere near the peak, as more than 50% of all confirmed cases were reported in the last two weeks," said Bishal Bhandari, a senior epidemiologist at analytics company Globaldata.

But he did allow for the possibility that the numbers may be due to increased testing.

"Increased testing is one of the possible explanations for the higher number of daily confirmed cases in recent days. It is also believed that actual numbers of undiagnosed cases are much higher, given India's low testing rate compared with the size of its population," said Bhandari.

Globaldata estimates it will take at least six additional weeks of continued strict social distancing efforts to reduce new positive cases to fewer than 1,000 per day.

Not only will the expansion of drug treatments help India battle the pandemic, it could also offer its API manufacturing industry a leg up.

So far, four Indian generic pharma companies – Cipla Ltd., Jubilant Pharma Ltd., Hetero Labs Ltd. and Mylan Laboratories Ltd. – have received nonexclusive licenses from Gilead Sciences Inc. to manufacture and distribute generic remdesivir in 127 countries.

"The choice of four Indian companies in the first round of remdesivir licensing itself lends weight to the capabilities of the country's generic pharma industry,” said Sasmitha Sahu, a pharma analyst at Globaldata. “All four companies are key generic formulation manufacturers with significantly large-scale API production capabilities. Cipla, Hetero and Mylan have a robust presence in the anti-infectives space with well-established supply chain capabilities.”

Other key COVID-19 repurposed drugs like favipiravir and hydroxychloroquine could also present new opportunities.

"With several countries contemplating compulsory licenses to facilitate the generic production of many potential COVID-19 treatments, other generic Indian pharma companies are also likely to be able to manufacture remdesivir,” Sahu said. “They may also look forward to producing repurposed drugs like favipiravir and lopinavir/ritonavir, which are being majorly evaluated in clinical trials across many nations.”

Others concur that this bodes well for India’s pharma industry and could even raise its competitiveness.

“India will continue to be a key exporter of pharmaceutical products due to its large and highly developed generic drug industry,” Sakshi Sikka, senior pharmaceuticals and health care analyst at Fitch Solutions, told BioWorld. “Pharmaceuticals are a major component of India’s trade expansion strategy, particularly with the country’s stated objective of a wider diversification of its export profile in terms of both products and export destinations.” She said her outlook for India’s domestic pharmaceutical industry is “broadly positive,” citing evidence of enhanced manufacturing capabilities and greater self-sufficiency in the production of both generic and sophisticated medicines as increasing its scope for international export opportunities.

“India's pharmaceutical export value was INR1,057.3 billion (US$14.9 billion) in 2019, which is forecast to rise to INR2,465.6 billion (US$30.8 billion) by 2024,” Sikka said. “Indian pharmaceutical companies account for 30% of the U.S.'s generic drug imports, with exports to the U.S. and other regulated western markets accounting for around 50% of the country's global medicine exports.”

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