Monthly Archives: September 2013

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

Need to move forward before trying to move ahead

Perceptions of the overall scenario

  • Overall CRO Market: Slow
  • Overall Outsourcing Market: Slow
  • Overall US Economy: Slow
  • Overall India Economy: Slow

If everything is slow then what is really moving. The whole matter comes down to the fact that has the thinking process of industry professionals has stagnated or slowed down.

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

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

In the business of outsourcing today for CRO’s where competition is stiff , CRO’s  and Sponsors need to find different ways of performing the same service.

“Creation” of innovative ideas to cater to sponsor requirements is the need of the hour. By giving the sponsor , the “routine” midday meal packaged “differently, will invite a better taste for sure.

Continue reading