With the next WHO inspection of Indian drug regulator due in March 2012, WHO country-head, India, Nata Menabde says state-level regulatory offices need to be strengthened. In a conversation with FE?s Soma Das, Menabde expresses her apprehensions on the new proposed drug pricing policy. Excerpts:
How do you rate the present Indian drug regulatory landscape?
There has been some major breakthrough in the Indian drug regulatory landscape since 2007, when the Indian drug regulator failed to pass the WHO inspection on basic requirements. Since then, atleast the central office (the Drug Controller General of India) has put its act together, the government pumped in resources, invested in the regulatory structure and the DCGI?s office has taken many initiatives on several fronts to catch up with global benchmarks. These efforts are definitely showing results.
In 2009, the Indian drug regulator passed the WHO inspection. Things should get better from hereon, as there is a proposal for increasing financial support further for the Indian regulator in the 12th five year plan. The next WHO inspection is due March-April 2012 and we hope that the Indian regulator will pass it.
However, what really needs to be strengthened now is the state-level regulatory offices.
Have you firmed up your views on the new pharma pricing policy?
We are still conducting our preliminary studies on the matter and it will take some time before I can share our final stance. But based on the experience of some other countries,we have apprehensions on certain parts of the new pharma pricing policy. Evidence elsewhere shows that when the reference for ceiling price has been tied to top brands, drug prices instead of falling may actually go up. That is our concern.
This policy may turn the high volume-low value drug market here into low volume-high value drug market. And India will lose its edge and uniqueness.
What is your take on the heightened interest of MNCS in the generic drugmakers here and the spree of acquisitions that have taken place recently?
We have definite concerns regarding that. Once Indian generic drugmakers are acquired by MNCs, they may have changed priorities.
These realigned priorities could lead to a tilt in the current balance if there is a change in the therapeutic profiles of the drugs getting manufactured and prices soar. We procure a major share of drugs from India which goes to other developing countries, specially in case of HIV drugs.
If these fear and speculation come true, the public health in poorer countries may suffer.
What do you think about the prevailing pharma marketing practices here ?
Although, it is a problem area worldwide, the pharma marketing practices here can get disturbing at times. Through a personal experience, I have seen doctors at times actually attend to sales personnel from pharma companies even as patients wait in queue. These practices should be more structured and disciplined and the patient should be accorded top priority.
The Srinath Reddy committee has just had a meeting with the planning commission on finalising the road map of universal healthcare coverage by 2022.
We at WHO have been fortunate enough to be consulted on this. The meeting at planning commission was very productive and positive and we think the recommendations on the road map to universal health coverage in the country is a step in the right direction.