Panel mulls drug export curbs to avoid shortage

NEW DELHI: A high-level committee constituted by the Department of Pharmaceuticals (DoP) is contemplating restrictions on the exports of some crucial antibiotics and vitamins in light of the coronavirus outbreak, said people aware of the matter. This comes as traders have been raising the prices of some bulk drugs for pharmaceutical companies amid the prolonged shutdown in China.

India imports bulk drugs from China to manufacture antibiotics and then exports finished products to other countries. The committee is mulling various measures to ensure that India doesn’t face any shortage of essential medicines in case the lockdown in China continues.

Bulk drugs or active pharmaceutical ingredients (APIs) needed to manufacture antibiotics like metronidazole, chloramphenicol and azithromycin aside from Vitamin B6 are imported from Hubei province, whose capital Wuhan is the epicentre of coronavirus outbreak. Hubei is also rich in minerals and India also imports borax, copper, gypsum, rock salt, coal and magnesium from the province.

“We are looking at the export-import data, the bulk drugs and the finished product which may get disrupted in the next few days in case the lockdown in China persists,” said a person who is part of the committee.

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“If need be, the export of these medicines may be restricted,” the person said.

The committee is examining the impact of the shutdown in China on the pharmaceutical sector in India. The DoP on Friday asked Central Drugs Standard Control Organization (CDSCO) to examine to what degree India depends on China for bulk drugs, possible shortages of molecules and measures that can be taken to keep the situation under control.

The committee of experts formed by DoP comprises Joint Drugs Controllers, officials from the directorate general of foreign trade and executives from pharma lobby groups. The lobby groups — Indian Drug Manufacturers’ Association (IDMA), Organisation of Pharmaceutical Producers of India (OPPI), and Bulk Drug Manufacturers Association (BDMA) of India — are working with the government to determine the stock position with pharma companies.

“We have written to the companies to share their inventory position with us — how much stock is available with them? If they have any Plan B in case their APIs get exhausted,” said another member of the committee.

India is dependent on China for a large number of APIs and intermediates required to manufacture pharmaceutical formulations.

China’s decision to extend the Lunar New Year holidays and the quarantine of more than 45 million could make imports of key raw materials difficult. At least 24 provinces, municipalities and regions in China have told businesses not to resume work before February 10. The Lunar New Year holiday was initially set to run from January 24 to 30, with work resuming on January 31. Hubei has told businesses not to reopen until at least February 14. Some expect the shutdown to be extended further.

“As of now we are ok,” said Cipla Global CFO Kedar Upadhye. “We store APIs and intermediates… we do store two months of stock as part of the inventory holding norms. So, if the plants do not start by end February, then it will become a delicate situation not only with us, but for entire pharma industry in terms of supply chain.”

Jiangsu province, which has over 128 pharmaceutical units, is more than 700 km away from the epicentre. Shandong province has 118 facilities that make APIs and intermediates on which India is dependent. “The situation will be clear in the next few days. If the lockdown continues, the pharma industry will face shortages.”

Traders dealing in bulk drugs or APIs in India have already started to increase prices sharply. APIs are key raw materials used to manufacture pharmaceutical formulations like tablets, capsules, and syrups. According to industry sources, on average, API prices have increased 10-15%. However, in some cases, the increase has been more than 50%.

The industry is bracing for difficult times ahead as the coronavirus spreads.

“We are already seeing the impact with a steep increase in rates of some key raw materials and seeing some shortages,” said Sunil Attavar, president of Karnataka Drugs and Pharmaceuticals Manufacturers’ Association (KDPMA). “The prediction that our overdependence on a single source of APIs and KSMs (key starting materials) is a strategic risk is unfortunately true. More than price increases the industry is afraid of shortages that will disrupt production and availability of some essential medicines.”