Category Archives: Industry Trends

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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

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

Clinical trials market in India-Will the same pick up in India?

This is the key question with analysts, investors and all stakeholders who have been observing this market in the recent times. The clinical trial industry since the year 2006 has been expected to grow in double digits because of its vast patient population.

However, things have not been bright for the industry particularly since 2009.

Data available at the Clinical trial registry of India has witnessed a step hike in clinical trial registration since it came into inception. On an international level, data at the Clinical trials Gov. site has also captured this aspect. Continue reading

The Indian Clinical Research Industry is going through a tough phase. Business in the industry is competitive because of a price war and a very stringent regulatory environment. The market was expected to reach a $ 1 billion in 2010 with a predicted growth rate of 15-20% but because of the prevailing recession and above mentioned factors, the market has yet to reach a size of $800 million in the year 2012-2013. The Industry desperately needs a growth booster. Experts of the industry also need to change the way they think about moving forward. Continue reading

The conventional use of social media is to connect with friends, near and dear ones. This concept exists worldwide. However the western world has been the first to tap the social media to its right use and that is why many good businesses thrive because of the social media. The pharmaceutical industry is no exception to the above rule.

Pharmaceutical industry in the west has picked up the social media for educating its customers i.e. patients and doctors Continue reading

Clinical Trial Market in India is in serious danger today. Day by day , the dangers are on the rise .  The supreme court coming out with a ruling that the CDSCO ( DCGI) cannot approve clinical trials till the laws are in place.

This decision is coming at a time when the industry needs “growth boosters.” This decision has come without keeping the real and the broader picture into perspective.

The questions now arise was this preplanned, or the same  has been just to  keep the industry professionals or regulators on the guard . Whatever may be the reason , the future 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

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.

Continue reading