Category — Pharmaceuticals

India’s Federal Government Withdraws Drugs and Cosmetics Bill

Keeping in mind the ‘Make in India’ initiative, India’s Federal government has decided to comprehensively review and revise the existing 76-year old drug laws on two important features: 1) to facilitate the ease of doing business, and 2) to substantially enhance the quality and efficacy of its products. The rewrite of the laws will take into account the regulation of biologics, regenerative medicines and clinical trials.

The Ministry of Health and Family Welfare has framed separate rules under the existing Act for regulating medical devices.The ministry is also working to bring about separate legislations for regulating medical devices and drugs and cosmetics.

A draft of the revised drugs law is expected to be ready in two months, top drug controller G.N. Singh told Reuters last week. “We thought it was better to revise the law than to put more bandages on it,” Singh said. He also mentioned that the government had requested regulators from the U.S. and Europe for input.



Meanwhile, the medical devices industry has welcomed the Cabinet decision. “AdvaMed appreciates the government of India’s efforts over the years to press forward with legislation that would create separate and appropriate regulations for medical devices,” said a statement issued by AdvaMed India, a forum of medical devices manufacturers.

“We view the withdrawal of the Drugs and Cosmetics (Amendment) Bill, 2013 as an opportunity to start fresh and consult with relevant stakeholders to draft new and globally harmonized legislation that would once and for all carve out distinct regulations for medical devices. This step is critical to the growth of the industry and — equally as important — to ensure that patients have access to innovative and lifesaving technologies,” added Advamed.


June 23, 2016   No Comments

J&J’s Janssen Pharma Supplies Tuberculosis Drug Free

Jannsen Pharmaceuticals, a part of New Jersey-based Johnson & Johnson Pharmaceutical Research and Development, has made available the drug Bedaquiline free to India  for use in hospitals in the cities of Guwahati, Ahmedabad, Chennai, Mumbai, and New Delhi only on patients who meet certain criteria for multi drug-resistant tuberculosis.

The Lokapriya Gopinath Bordoloi TB Hospital in the north eastern part of India has become the first state in Asia to offer this drug exclusively to patients who have failed to respond to standard first-line and second-line anti-TB drugs, reports BioSpecturm.
Nayan Jyoti Das, the joint director of health services and the state officer for India’s TB control program, said, “Many TB patients develop resistance to several drugs. But with the launch of bedaquiline, it will be possible to treat such patients.”
TB remains a global epidemic with over two billion people harboring its latent infection and more than 9 million cases of which 500,000 are multi-drug resistant (MDR-TB). India accounts for 23 per cent of global TB cases and deaths. An estimated 2.2 million people suffer from TB in India with over 70,000 MDR TB patients.

June 20, 2016   No Comments

Templeton Sees India Growing at 10% Shortly

Mark Mobius, Executive Chairman, Templeton Emerging MarketsGroup, is positive on India and believes the Indian economy is on a strong footing. “I can see India growing at 10% in the next few years if reforms continue to kick in,” he said in an interview with Business Standard. “We have  $2 billion plus investments in India and we want to increase it,” he added.

Mark Mobius

Mark Mobius

Excerpts from the interview below:

The  investment sectors of interest in India:  “Given the fact that the country is growing and with the on-going reforms, banking is the obvious selection to begin with. And some of the conglomerates, companies that are involved in a number of sectors and getting a wider exposure of the markets will be another area. We also like technology and pharmaceuticals. We have a mix of both public and private bank stocks in our India portfolio.”

Two years of Modi’s Government:  “The emphasis of the Modi government on the low income segment of the population is very good. I believe it not just a populist move but is also a key element in making the Indian economy healthy because you are creating a whole new generation of consumers and people who are becoming more productive. The Modi government’s emphasis on empowerment rather than hand-outs is very good.”

U.S. Federal Reserve is  expected to increase rates; trajectory down in India; FIIs pulling money out of Indian debt. How do you see things playing out?:  “This trend will continue. As long as you continue the reforms of the financial system in India and make it more transparent and efficient then rates will come down. If you see a more efficient productive society with less restrictions, your inflation will come down and interest rates will fall. This should have been done a long time ago. The emphasis of the government on the less fortunate segments of the society is very critical. The fixed income side will see some impact.”

Whether GDP growth of 8% is possible in India:  “It (8% growth) is quite possible. I can see India growing at 10% in the next few years if reforms continue to kick in. I believe the numbers are reasonably accurate, give or take half a per cent.”





June 6, 2016   No Comments

TIME honors Tata Steel, Hero Moto, Ajanta Pharma

In January, at the World Economic Forum in Davos, Switzerland, nine companies in sectors ranging from automobile engineering to steel manufacturing were named as the finalists for the inaugural TIME India Awards that encompassed three categories—Best in Class Manufacturing, Manufacturing Innovator of the Year, and Young Maker of the Year.

PM Modi at TIME India Awards

PM Modi at TIME India Awards

On February 13, Norman Pearlstine, Chief Content Officer for TIME Inc., announced the winners at a ceremony in Mumbai at which Indian Prime Minister Narendra Modi was the guest of honor. The awards kicked off a week-long series of events to mark the Indian government’s “Make in India” initiative to boost the country’s manufacturing sector.

The Best in Class Manufacturing award was given to Tata Steel, while the Manufacturing Innovator of the Year award went to Hero MotoCorp, and the Young Maker of the Year award went to Yogesh and Rajesh Agarwal of Ajanta Pharma, reports TIME.

“The recipients of the first TIME India Awards are world-class companies that are making a real impact on the rapidly growing Indian economy,” said Pearlstine. “We are pleased to recognize them for their efforts during Make in India Week.”

February 13, 2016   No Comments

Emcure Pharmaceuticals, India, Acquires Ottawa company

Emcure Pharmaceuticals, a drug maker based in Pune in the western state of Maharashtra, has acquired Canada‘s International Pharmaceutical Generics Ltd. and its marketing arm Marcan Pharmaceuticals. Marcan Pharma has over 60 approved products mainly available from McKesson and Kohl & Frisch, among other wholesalers, reports Economic Times.

Emcure recently estimated its annual global sales at over $670 million having widened its base from contract manufacturing. The company has a strong presence in India, U.S., and European markets.

Emcure’s entry into Canada is similar to the strategy it had adopted during the acquisition of U.S.-based Heritage Pharmaceuticals in 2011. Emcure’s support to Heritage accelerated its U.S. sales for FY 2016 to $265 million. Industry experts say that Canada could be attractive for Emcure, although there could be challenges as the Canadian government implements a reference pricing system.

January 31, 2016   No Comments