Category Archives: DCGI

Archives

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

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

Self regulation was definitely there with the Industry. Otherwise the business would not have been growing.

In a country like India where majority of the population is not so literate and not so rich, change their “integrity” for their “rights” and ultimately suffer at the hands of people who just want their own mileage. The people who are involved in the law making process do not have the relevant expertise nor the understanding of the business process. Hence the they get incited easily when something like death, or other adverse reactions takes place because of the disease itself and not the trial. Things take an ugly turn when the matter goes to courts and livelihood of people is affected. Moreover, the population which requires cost effective drugs/ new drugs for their diseases suffer too.

Continue reading

” The Export growth drivers for the Indian Pharmaceuticals since the last 5 years have been mainly the Test Licenses and the Import license. The Test licenses are an indication of the “”growth of the outsourcing and in house conducted Bio equivalence studies for off patent Generic Drugs””. Needless to say, that the importance of generic/ off patent drugs in the geographic regions outside India is rising. If the market capitalization were to be mapped from 2006 to 2009, an increase by 3000 test license applications has been observed.
Another Interesting point is that from the year 2008 to 2009, there has been an increase of 600 applications in the category of BE for exports.
New drug applications are an area which has taken a back seat and the same is because of the regulations under Schedule Y for Phase for molecules discovered outside India. There has been sudden rise in applications for vaccines in particular from 2008 to 2009. Many MNC’s are capitalizling the same on the widespread onset of flu as well eyeing stakes/ acquisitions in Indian vaccine manufacturing companies.”