Last Updated on November 14, 2019 by The Health Master
New Delhi: Three top-selling drugs for malaria, leprosy and certain cardiac conditions are set to go off shelves in 12 months as their manufacturers are pulling the products out of India.
The drugs are Abbott Healthcare’s leprosy drug Hansepran, Sanofi’s Adenocor, used to treat certain kinds of abnormal heartbeats, and Bayer Zydus Pharma’s anti-malarial medicine Resochin. Alternatives to all three are believed to be widely available in the market.
The companies are among four that applied to the drug watchdog National Pharmaceuticals Pricing Authority (NPPA), which is responsible for maintaining the supply of medicines in the country, for discontinuation.
The fourth is Indian company Mankind, which is pulling the painkiller Mefkind P Suspension and Clindatime capsules, an antibiotic.
The companies have assured the government that alternative medicines by other brands are widely available.
While the government has allowed their application, the NPPA has asked all four companies to continue production for a certain period after the date they intended to cease manufacture. “Sudden discontinuation could lead to shortages” the NPPA noted in a meeting on 30 October, the minutes of which have been accessed by ThePrint.
The NPPA has directed three of the companies — Abbott Healthcare, Sanofi and Bayer Zydus Pharma — to continue production for 12 months beyond the intended date of discontinuation, while Mankind has been asked to continue production, import and sales for six months.
‘Shortage of raw material’
While Hansepran accounts for 98 per cent of the market share in its segment in India, Adenocor, which is also used as a diagnostic aid during stress tests for the heart, is also the market leader with a share of 43.62 per cent. Resochin accounts for 12 per cent of the market, while Mankind has less than 10 per cent.
Approached by ThePrint for comment, US-based Abbott Healthcare blamed the shortage of raw material in India and increased cost of production.
“Abbott has applied to the NPPA for discontinuation of Hansepran 50 mg and Hansepran 100 mg due to unavailability of the active pharmaceutical ingredient (API) in India, and increased costs from the alternate [sic] supplier outside of India,” a company spokesperson said via email.
French Pharma major Sanofi Synthelabo, meanwhile, suggested the commercial opportunity was small.
“As part of our regular review of therapeutic portfolios, we sometimes discontinue products when there are sufficient appropriate and alternative medicines for patients, and the overall commercial opportunity is small,” a Sanofi spokesperson said.
Resochin, according to the NPPA minutes, is the second anti-malarial medicine to apply for discontinuation.
“The company has about a 12 percent market share for this critical medicine for malaria whose major producer IPCA Laboratories has also applied for discontinuation,” the minutes state.
It’s not clear whether IPCA’s application has been accepted.
Bayer Zydus Pharma, a joint venture between Germany’s Bayer Healthcare and India’s Zydus Cadila, did not clarify the reason behind discontinuing its anti-malarial drug, just saying that “we regularly analyse our portfolio and make adjustments where necessary”.
“In realigning our portfolio priorities to better address areas of high unmet medical needs in the future, Bayer Zydus Pharma has opted to discontinue the marketing and distribution of Resochin in India,” it added.
A senior official at the Department of Pharmaceuticals, the parent organisation for the NPPA, said the “drug was no longer commercially viable for the company”, but Bayer Zydus Pharma did not comment on it.