Pharma News Analysis

Indian CRO ( Clinical Research Outsourcing ) Industry " Panel Requests Tighter Rules Against Clinical Trials"

I do not know how much impact the following will have and if anything will change... My opinion is that a lot of this is noise...but it certainly is something to keep in mind for those of you involved in Clinical Research Outsourcing to India. It is from Times of India:

"The committee has raised concerns over implementation of the good clinical practice guidelines (GCP) and ethical norms.

"Though the concerns regarding involvement of women in clinical trials have been specifically addressed in Indian GCP guidelines, the committee is doubtful whether these are being followed in letter and spirit," the report said.

Adding that most scandals about clinical trials revolved around issues like whether the patient knew about being part of the trial, whether informed consent to participate was taken or not and whether the patient was told about the possible side effects and risks.

The committee has asked the government to make the conditions for clinical trials more "stringent" and introduce clear guidelines on compensation. The committee, headed by Delhi MP Krishna Tirath, recommended an amendment to schedule Y making the trials easier.

The committee reviewed the family planning methods prevalent and opined that the entire contraception programme of the government had become women-centric and male sterilization had been put on the backburner. "

Source: http://timesofindia.indiatimes.com/rssarticleshow/3010486.cms

An Insider's View on Pharmaceutical Outsourcing

Since 2001, I have been working with Senior Executives from Pharmacutical industry to develop and implement outsourcing and off-shoring strategies. Seven years later, I am still asked by industry insiders and those from outside asking me if I still think Outsourcing has any legs? NO, I AM NOT KIDDING!

So, here goes a bit of my own perspective:

Pharma industry has been outsourcing for a long time. It is NOT a new phenomenon. Yes, acceptance of outsourcing and off-shoring to India and China may be relatively new (new meaning post 2000).

Yes, I believe and support that Outsourcing is here to stay. However, I believe that Outsourcing will increase even more. The types of deals and their complexities will be even more and across the value chain.

"Learning While Earning": Look for some outsourcing companies to move up the value chain - especially from India and China.

Regional / Country Wide Subsidiaries to play a big role: Country managers in India, China and Russia will (or SHOULD) play a bigger role in managing outsourcing relationships.

Small and mid-sized Outsourcing companies in the US and EU will find it difficult to justify their existence - unless they provide unique and compelling value proposition.

Look for consolidation, mergers, acquisitions and more joint ventures in 2008.

PE, VC and Institutional investors are pouring in more money in India and China.

New Countries/Regions/Economies to play a role: Some of my clients are already looking towards Phillipines, Brazil and Russia.

Watch Accenture, GVKBio, WuXi Pharmatech, Hikal, Jubilant, Quintiles, Siro, iGate, Degussa, Lonza, Zydus, Divi's Labs very closely.