Covid-19 impact: Government panel lists essential drugs that can run out.

A government committee has identified various essential drugs including key antibiotics such as amoxicillin, moxifloxacin, doxycycline and tuberculosis (TB) drug rifampicin that could run out as supplies of bulk raw materials from China have been disrupted because of Covid-19 outbreak.

A high-level government committee, which submitted its report to the Department of Pharmaceuticals (DoP) last week, reviewed 54 drugs and said that out of these, 34 have no alternative.ET has seen the report.

Out of the 54, it classified 32 as critical and essential, 15 as noncritical and essential and seven drugs as essential.

Govt Calls Series of Meetings Today

Some of the active pharmaceutical ingredients (APIs) used to make critical and essential drugs that don’t have alternatives include potassium clavulanate, ceftriaxone sodium sterile, piperacillin tazobactum, meropenam, vancomycin, gentamycin and ciprofloxacinamong others, according to the report.

The panel had earlier asked India’s top research body, the Indian Council of Medical Research (ICMR), to review drugs totally dependent on China-made APIs and provide inputs on alternatives.

The drugs belong to various therapeutic categories. Of the drugs reviewed by the ICMR, 38 are covered under the National List of Essential medicines (NLEM) and Schedule 1 of the Drug Price Control Order. Drugs covered under NLEM should be available within the health system in adequate amounts and assured quality. Also, medicines listed in the NLEM must be sold at a price fixed by the National Pharmaceutical Pricing Authority (NPPA).

In the light of new cases emerging in India, the government has called a series of meetings on Tuesday, said people with knowledge of the matter. The ICMR has asked pharmaceutical experts to finalise a white paper on securing access to essential medicines. Another meeting has been called by India’s drug regulatory authority to discuss the current status in China with respect to resuming production activities, logistics and percentage of staff reporting on duty. The commerce and industry minister will also hold a meeting to discuss global disruptions in supply chains and their impact on India, said the people cited above.

The lockdown in China has already put companies on their toes. “Amoxicillin is the most commonly used API used to manufacture antibiotics like Moxikind-CV,” said Mankind chairman and managing director RC Juneja. “Fearing that there could be a shortage if the situation continues in China, we have invested ?100 crore in placing irregular orders with vendors. However, if this continues till April mid, there will be an acute shortage.”

Doctors are also concerned about shortages of critical drugs such as rifampicin. “This drug cannot be discontinued and it will lead to a big disaster if there is a supply disruption,” said a doctor, requesting anonymity.

India is dependent on China for a large number of APIs and intermediates required to manufacture pharmaceutical formulations. “Considering the criticality in respect of these APIs and KSMs (key starting materials), the committee had requested ICMR to provide the inputs with respect to the alternative for these drugs,” added the report.

The list includes antibiotics such as azithromycin, amoxicillin, ofloxacin, metronidazole, vitamins such as B12, B1, B6, and E, female hormone progesterone and atorvastatin among others. The expert panel had also asked drug manufacturers to share their inventories.

Besides this, as reported by ET first, the panel has also recommended restricting exports of 12 drugs, APIs of which are imported from Hubei. The province’s capital Wuhan is the epicentre of the coronavirus outbreak.

The committee, which was tasked to examine the impact of the shutdown in China on the pharmaceutical sector in India, submitted its report on February 27. The DoP had constituted the committee of experts to examine how much India depends on China for bulk drugs, possible shortages of molecules and measures that can be taken to keep the situation under control.

The panel comprised the joint drugs controller, officials from the directorate general of foreign trade and executives from pharmaceutical lobby groups — the Indian Drug Manufacturers’ Association (IDMA), Organisation of Pharmaceutical Producers of India (OPPI) and Bulk Drug Manufacturers Association (BDMA). They had been working with the government to determine the stock position at pharma companies.

Earlier, India’s drug pricing regulator had examined the availability and stock position of three major APIs and KSMs such as penicillin G, tetracycline and paracetamol.

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 such as 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%.

Source:

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