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Indian pharma set to sprint

In the battle to tame the novel coronavirus, it appears drugs have started gaining ground. Even as a vaccine seems a while away, more than a dozen versions of the two known drugs — Remdesivir (injectable) and Favipiravir (tablet) — have hit the Indian market.

Scientists are claiming progress in the effectiveness of ‘repurposed’ drugs from these established brands. Medical practitioners, on the other hand, are reporting encouraging results from the use of the drugs. Repurposed drugs are new variants of the already approved drugs in the market which can be tailored for the intended new use.

In the absence of a definite antiviral developed to contain the virus, doctors are guided by ‘symptomatic treatment’, for which they are choosing the repurposed drugs available and with some backing of trials done and regulatory approvals. Existing drugs like Hydroxychloroquine and Dexamethasone too are in regular use.

With cases rising by tens of thousands every day, the challenges are huge. The silver lining is that Indian pharma has quickly risen to the task. Interestingly, it has been so fast that a price war has already erupted in the market.

Within a couple of months, the drug prices have fallen to about Rs 35 per tablet from hundreds per dose as drug majors like Cipla, Glenmark, Hetero, Sun Pharma, Lupin, Zydus, Jubilant, BDR Pharma, Optimus and AVRA Labs have thrown their might to both manufacture under licence and make their own versions and bring them to the market. A good number of companies from Hyderabad are active players.

That the Indian pharma industry has emerged as a formidable contributor to cost-competitive generic drugs in the global market is known. It has proved itself repeatedly by developing cost-effective drugs to combat HIV/AIDS to many generic versions of a range of drugs to treat myriad ailments over the decades.

Challenge and Strengths
In the face of the global health crisis posed by the coronavirus since January, the Indian drug sector to its credit is making serious efforts to rise to the task. The government too has been positively responding to the needs of the domestic companies.

Consequently, when demand for the antimalarial HCQ suddenly shot up after US President Donald Trump articulated its effectiveness, the Indian government reacted by coming in support of Indian manufacturers. It also pushed for the revival and fresh grants to Bengal Chemicals & Pharmaceuticals Ltd, the original maker of the drug from pre-Independence.

The large number of US FDA-approved manufacturing units and manpower give Indian drug companies a competitive advantage in the global arena. Though, issues of quality and repeated inspections by international regulators of some production facilities cause concern periodically.
It’s no wonder then that within a few months, at least a dozen generic versions of Favipiravir, the oral, antiviral, originally developed by Toyama Chemical Co, a subsidiary of Japanese pharma major Fujifilm, have been launched by Indian companies. Starting from Glenmark’s brand FabiFlu to Cipla’s Ciplenza and Sun’s Flu Guard, the domestic market is getting beefed up rapidly to meet the demands. Interestingly, the drug was used to treat Influenza and, therefore, some experts are seeing better results in the treatment of Covid symptoms.

On the other hand, Remdesivir, an injectable, originally developed by Gilead Life Sciences, was out-licensed to three Indian firms in June—Cipla, Hetero and Jubilant Lifesciences. In a few more weeks, Zydus and Mylan joined the competition with their own versions. Though priced very high initially and facing criticism of ‘exploitation’ by the public, the drug firms have quickly started scaling down the prices.

Weakness & China Challenge
While the story so far reads positive in mounting an encouraging response to the Covid crisis, a bigger problem lies ahead, warn experts. If India has to emerge as a formidable player in the post Covid scenario, it has to regain its self-reliance in bulk drug manufacture and give a boost to the production of APIs (active pharmaceutical ingredients).

The overdependence on China for import of raw materials, medical devices and a range of products due to considerations of price advantage threatens to impact the country’s strengths in the long run. The deteriorating political and trade relations between India-China too do not augur well for India. For example, in antibiotics and steroids, China is a virtual monopoly.

According to estimates, India imports 65-70% of its bulk drug and intermediates. Pharma exports too registered a slight decline in February-March due to the virus and impacted the overall performance during fiscal 2019-20, said Uday Bhaskar, Director General of Pharmexcil.
The Modi government had made some significant announcements in March with a Rs 14,000-crore package to boost domestic production of APIs and a range of medical devices in a bid to reduce dependence on imports for critical healthcare.

For the drug industry, it came up with a scheme to help establish three bulk drug parks over the next 5 years with a proposed investment of Rs 1,000 crore in each with the identified States providing the land required. It has followed up with guidelines to encourage bulk drug production with incentives. These measures during the Covid crisis have been welcomed by the industry.

Firm Strategies
Pharmexcil, the industry body, has been urging the government to set up exclusive clusters for the manufacture of basic chemicals and intermediates in different parts of the country. It is also firming up a strategy to reduce the dependence on China for import of APIs. Interestingly, as the Chinese offered APIs at very low prices, the Indian majors found imports cheaper than domestic production. India has found itself in a difficult situation now. The effort to reverse the situation is both tough and time-consuming, say experts.

Though the Union government has initiated a combination of investments and tax incentives, the real test lies in translating them into action quickly and for pharma companies to launch a time-bound, realistic plan with commitment.

With a pharma industry of $36 billion in fiscal 2018-19, at least four Indian companies in the top 10 generics manufacturers and being the largest vaccine producer, the Indian drug industry has all the trappings to forge ahead in the Covid and post era, if it can get its act together.

M Somasekhar is senior Journalist & former Associate Editor, The Hindu BusinessLine. – Telangana Today

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