Supreme Court Suspends New Drug Trials in India…Time to Shape Up?

On September 30, 2013, with a damning stricture to the Drug Regulator, the Supreme Court, in response to a Public Interest Litigation (PIL) filed by the NGO Swasthya Adhikar Manch, stayed approvals for 162 applications for local Clinical Trials (CTs) of new … Continue reading

The ruckus over Clinical Trials in India compels Government tightening regulations before flooring gas pedal for regional leadership

The subject of Clinical Trials in India has created a huge ruckus, mainly for wide spread alleged malpractices, abuse and misuse of the fragile regulations of the country by the players in this field. The issue is not just of … Continue reading

Quick implementation of the undiluted ‘Central Drug Authority (CDA)’ Bill is essential for emerging India

Many industry experts after having evaluated the provisions of the original draft proposal for forming a Central Drugs Authority (CDA) in the country, commended and supported this laudable initiative of the Government. This Bill also known as, “The Drugs & … Continue reading

EU-FTA, TRIPS-Plus provisions, Data Exclusivity, Public Interest and India

Business Standard in its January 27, 2011 edition reported, “Data Exclusivity still key hurdle to India-EU FTA” Before deliberating on this important issue of “Free Trade Agreement (FTA)”, let me touch upon very briefly, for the benefit of all concerned, … Continue reading

To restore patients’ confidence MCI has amended its regulations… to strengthen it further will the government consider an Indian version of ‘Physician Payment Sunshine Act’?

In today’s India, blatant commercialization of the noble healthcare services has reached its nadir, as it were, sacrificing the ethics and etiquettes both in medical and pharmaceutical marketing practices at the altar of unlimited greed. As a result of fast … Continue reading

Amendment of ‘Professional Conduct, Etiquette and Ethics’ Regulations for the Doctors by the MCI could dramatically change the Pharmaceutical Marketing Practices in India, hereafter.

As reported in the media, the notification of the Medical Council of India (MCI) dated December 10, 2009 amending the “Indian Medical Council (Professional Conduct, Etiquette and Ethics), Regulations 2002″ has been welcomed by the medical profession. Areas of stricter … Continue reading