Category Archives: Indian Pharma

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The ‘Make in India’ campaign by Prime Minister Narendra Modi has 25 sectors in focus including Pharmaceuticals and Chemical sector. This may proven to be a booster dose to the Pharmaceutical Manufacturing Industry.

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The Make India campaign will result in attracting investment from foreign markets. The government has already created a dedicated online cell to answer queries from all over the globe. Primarily, the ‘Make In India’ focuses on zero defect and zero effect. In which zero defect means products which are manufactured in India should not be rejected in the overseas market. Zero effect means that the manufacturing should not have any negative impact on the environment. Continue reading

‘Make In India’ is focusing on Pharmaceutical sector this week. Considering India as one of the major markets for Pharmaceuticals in the world this is a great move. Right from the beginning there has been much hype about Indian Prime Minister Mr. Narendra Modi’s dream project ‘Make In India’. According to experts the program is promising and will have great and enduring effect on Indian economy through manufacturing industry.

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The Indian generic drug industry is the largest supplier of medicines worldwide and US is the largest consumer of the same. One of the leading companies, a leading generic manufacturer which is also the leading supplier of generic medicines to the US has come under the FDA scanner since the last 12 months.  The trigger to the Ranbaxy problems came when Dinesh Thakur , ex-Ranbaxy employee, acted as the whistleblower. The same came out as an action from the FDA when Ranbaxy’s key manufacturing plants in India went on a spree of Imports alerts and 483’s. To add to the problems, even Ranbaxy’s’ US based plants came under the FDA lens.

 The problems were many:

  • Response from the Indian regulated DCGI to the Ranbaxy fiasco came only after the FDA warnings to Ranbaxy
  •  Internal conflict within Ranbaxy between the ex-owners, Malvinder Singh and Diachii Sankyo occupied the front pages of the media Continue reading

Reduced production

In the recent economic slowdown where the industrial sector in India has been grossly affected, the Pharmaceutical Industry is no exception. The Pharmaceutical Industry has been facing pressure on the export front because of the ups and downs in the dollar, stricter laws from the US FDA, increase in the generic drug fee of the ANDA dossier, rising manufacturing costs, rising cost of the raw material, pricing pressures (DPCO) and the Pharma MNC’s trying to buy out existing units in Indian and trying to increase their geographic presence.

Even semi regulated markets are in the process of enforcing stricter regulations for exports of medicines from India. Continue reading

There has been a spate of import alerts on Indian Pharma by the US FDA in the last few months. Is the US FDA trying to say that the Indian Pharmaceutical manufacturers are not quality conscious or are they trying to protect their domestic industry by citing “superior” quality standards.

The US is the largest consumer of generic drug medicines manufactured by Indian Pharma and this trend is on the rise particularly since the last decade. Continue reading

Excessive Scrutiny

The US FDA has issued an import alert to Ranbaxy for non compliance. Is this justified considering that the US is the largest consumer of Indian made medicines since many years?

A recent fact sheet on generic drugs says:

  •  Around three-quarters of prescription medication in the U.S. are generics. Some reports put that number at 84%, with predictions as high as 87% for the near future. Meanwhile, research firm IMS Health found that, in 2012, money spent on prescription drugs decreased by 1%. It was the first such drop since IMS started tracking numbers in 1957. Continue reading

Compulsory licensing for manufacturing of off patent anti cancer drugs: Indian govt.’s decision to aid cost effective availability of medicines to the masses. Will this aid the ailing Indian Pharma?

Affordability to anti cancer drugs in the India is a major shortcoming for the majority who are affected.  The government of India is running a campaign for making available cost effective anti cancer medicines to the affected people. This is visible on terms with media campaigns particularly on TV and newspapers.

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Indian makers of generic drugs have a fight on their hands as they scramble for access to the $100 billion worth of drugs coming off patent over the next two years.

Fierce competition and lawsuits from rival generic firms, a stricter U.S. health regulator and compliance issues are some hurdles Indian pharmaceutical firms face in their race to grab the opportunity

Indian drug firms, which account for about a third of U.S. applications for approval to sell generics, could add $2 billion to $2.5 billion in U.S. sales in the next five years, doubling their revenue from the country, according to Morgan Stanley.  But that opportunity will not be easily won and investor sentiment is reflected in the decline in share prices.

The Indian pharmaceutical index is down more than 9 percent this year, versus a near 6 percent fall in the broader market.  Drugs worth more than $140 billion are likely to go off patent in the next five years, analysts said, and the right to sell blockbusters such as Lipitor will be especially contentious

Generics are poised to increase their market dominance in the next few years in the United States, driven by the wave of patent expirations, rising from 77 percent of prescriptions in the first half of 2010 to as much as 85 percent by 2014, according to a forecast by IMS Health Inc.  Health insurers, pharmaceutical benefit managers and other healthcare payers also push consumers to use generics to help control spending after the U.S. government enacted a broad healthcare reform law last year. The next two to three years is going to be good. Lots of Indian companies are well-geared for exploiting this market. Turnover will zoom, profits will zoom.

However, there will be lots of lawsuits. It is going to be extremely competitive. The FDA will be a lot more diligent. At the end of December, Lupin had 137 applications filed with the FDA, with 47 approvals won to date.

Lawsuit Trouble

With so much at stake, rival generic drug makers such as Israel’s Teva and Mylan, as well as the patent holding companies, are expected to leave no stone unturned.  In its lawsuit, Mylan contends that Ranbaxy, controlled by Japan’s Daiichi Sankyo , should be forced to forfeit its exclusivity period to sell Lipitor because it violated the FDA’s application integrity policy. A victory for Mylan could cost Ranbaxy $500 million to $600 million in revenue.  Analysts expect Ranbaxy, whose shares have lost 23 percent so far this year, to launch generic Lipitor in November, given U.S. approval of its generic version of Pfizer’s Alzheimer’s drug Aricept and its plans to move the manufacturing of generic Lipitor to New Jersey from Paonta Sahib.

While that may placate regulators, moving manufacturing to the United States also undermines the cost advantage of producing in India.  There is plenty of opportunity for generics. But unfortunately competition is very fierce both from big pharma and incumbent generics.

The EU India FTA dispute has been resolved

The EU and India have resolved a dispute about the seizure of generic medicines passing through Europe en route to Africa and Latin America. In 2009, the EU repeatedly seized generic drugs originating in India as they passed through European ports on their way to Brazil.

The World Trade Organization dispute was initiated by India and supported by Brazil. The EU made the seizures on grounds of patent infringement, but India and Brazil disagreed with those claims. As a result of India and Brazil’s concerns, the EU is examining its rules that triggered the disputes. By amending customs codes the EU plans to stop the seizure of generic drugs passing through European ports en route to Latin America and Africa. In the past shipments of drugs, legal in the exporting and importing countries, were stopped because they were not recognized in the EU. Transports in transit will no longer be checked, except for counterfeiting.

Current Scenario

An EU-India summit in Brussels, Belgium, in December 2010 has strengthened the strategic partnership between the regions and furthered free trade agreement (FTA) negotiations. Over the last seven years, bilateral trade has already doubled. A stronger partnership between the world’s biggest political Union of 27 democracies—the EU and the biggest democracy in the world—India, will be welcomed, not only for its economic potential, but also its huge political potential.

A Promising Prediction/Forecast

In January 2011, consultants Fitch Ratings said ‘the outlook for Indian generic pharmaceuticals for 2011 is stable. Earnings and profitability of Indian generic-based pharmaceutical companies will benefit from continued demand for generics. Fitch expects the US market to be the main growth driver for the demand of generics, while the Indian domestic market will continue to remain buoyant. There is a good possibility of further interest in partnerships between global innovator and Indian generics companies.