Shirish K Dabhade, President, AIDCOC speaks with Usha Sharma about the various challenges faced by the pharma industry and the reforms he intends to bring about in his tenure to tackle these challenges
What are the highlights of your journey so far in the life sciences industry?
I was a drug inspector for 18 years and also a lecturer. I was nominated as a Assistant Commissioner in January, 2011, by Maharashtra Public Service Commission as Assistant Commissioner since January, 2011.
Having been elected as the President of All India Drug Control Officers Confederation (AIDCOC), what vision and mission do you foresee during your tenure?
Our mission is to achieve professional excellence through continuous training, better coordination with the Drugs Control Officers. More interaction with fellow pharmacists is required to establish a vital link between the pharmacist and regulatory officers in the chain of healthcare delivery.
My vision is to achieve professional excellence through concentrated efforts in thrust areas like seminars, interaction and social commitment.
A training academy for all Drugs Control Officers of India needs to be set up. Apart from this, officers from State Drugs Control Organisation, should be bought under the purview of AIDCOC.
Currently, how many posts are lying vacant for drug inspectors?
With regards to the recommendations made by different committees such as Hathi Committee, Dr Agarwal Committee, Dr Mashelkar Committee etc. the requirement ratio of the inspectors to the selling establishment is 1:100, i.e. for every 100 selling establishments of medicines, one inspector is required. As regards to the state of Maharashtra, the sanctioned posts for the drugs inspectors are 161 out of which about 30 odd posts are lying vacant.
Recently, the Government of Maharashtra has appointed 63 inspectors and few more are expected to join in near future. Fortunately, the Mahesh Zagade, Commissioner of FDA, Maharashtra, has realised the disparity and shortage of the enforcement staff. He has proposed a comprehensive change in the set up of FDA, including filling up of posts for drugs inspector from existing 161 to about 1,000. Similar efforts are in progress across various states like Andhra Pradesh, Rajasthan, Jharkhand, etc.
Pharma companies are complaining that the waiting period for getting approvals and patents have increased in the recent past due to these vacancies. In your view, have the vacancies impacted the approval process to the extent claimed? What measures are you going to take to overcome this issue?
The requirement of appropriate infrastructure along with the staff is the need of the day not only to ensure the safe, efficacious drugs at reasonable price but also to perform, deliver and meet the requirements for the development of the country. Without providing proper staff with appropriate infrastructure, it will be unprofessional to expect the officials to perform professionally. The committees have reiterated the pressing need for strengthening the Drugs Control Offices in states as well as at the central level. There is a need to completely restructure the enforcement setup to deal with different issues, not only in just licensing but also in post marketing surveys, pricing, advertisements, with support and use from Institute of Chemical Technology (ICT).
What is your view on the recent announcement regarding the appointment of new Drug Controller General of India (DCGI) for an interim period of three months? Kindly comment on the ongoing controversy regarding the eligibility criteria for the appointment of a DCGI?
Our basic concern is the rectification in the recruitment rules for DCGI with respect to qualification and experience as per Drugs and Cosmetics Act. The irrelevant criterion of scale grade was added to restrict eligible and competent candidates available across India. Unless this is addressed, we will pursue the matter.
Please elaborate on the need for a Drug Information Centre programme. How will it be beneficial for end users? What is the current status about the programme and when will it be launched?
Presently, the idea of such an initiative has been dropped. But we are helping out State Pharmacy Councils to gear up with the same. Recently, there were reports in the media that AIDCOC will soon approach the Union Public Service Commission (UPSC) for including pharma science as an optional subject list for UPSC’s civil services examinations.
Kindly brief us on the same and what action has been taken by the UPSC body?
This is the vision wherein pharmacy professionals intend to contribute in the administration, to be more precise, in healthcare management. Professionals in medicine, engineering, commerce, veterinary sciences, etc. can participate in the competitive exams with specialised subjects they have studied, but pharmacy professionals do not have a level playing platform as pharmacy is not taught in the main course. We are taking up the matter with the UPSC.
Schedule Y was amended to Schedule Y1 in order to restructure and streamline CROs and the conduct of clinical trials in India.
In November 2011 there were reports that the Union Health Ministry is planning to notify Schedule Y1, after controversy broke out regarding the number of deaths related to clinical trials. What are your views on this?
Strengthening of the enforcement machinery will definitely help in monitoring such facilities and such incidence can be avoided.
What other programmes are on AIDCOC’s agenda for 2012 and beyond?
We will organise AIDCOC’s convention in Bangalore where social initiative programmes such as medical camps in remote areas, blood donation camps, consumer awareness workshops will be held. All officers should communicate among themselves through social networking sites. Would like officers from across India to have international training and from each state’s Drugs Control Officers should be represented at international symposia through the Central Government.
There should be uniformity in designation and pay scale for the drugs control officers across the country.