Pharmabiz
 

Transparency and efficiency, key for regulations

Thursday, December 15, 2011, 08:00 Hrs  [IST]

From computerization & networking of the Karnataka Drugs Control Department for issue of pharmacy trade & manufacturing licenses; operating three drug testing labs at Bangalore, Hubli and Bellary and strengthening the state intelligence wing, Dr. BR Jagashetty, Drugs Controller, government of Karnataka has proved that transparency, accountability and efficiency are the key for proper regulation. At a national level, he is also the member of the Drugs Technical Advisory Board and chairman of Committee on the Amendment of the Drugs & Cosmetics Rules. As the chairman of the Local Organizing Committee for the 63rd Indian Pharmaceutical Congress ,  Dr. Jagashetty provides a bird’s eye view of the pharma industry in the state, issues the sector faces and the transformation of Bangalore since the last IPC in January 1993, in an interaction with Nandita Vijay. Excerpts:

As the chairman of the Local Organizing Committee for the 63rd IPC and as the president of the IPA Karnataka State branch, would you be able to give us a snapshot of the state's progress over the years and the biggest changes in the sector since the last IPC in Bangalore?
Karnataka and Bangalore have  witnessed a sea change in the area of pharmaceutical development since the last IPC held in January 1993. There has been a profusion of industries covering formulations, active pharmaceutical ingredients (APIs), medical devices / technology, manufacturing equipment, packaging machinery etc., to name a few. In the pharmacy trade , there has been an increase in the number of licenses from a mere 8,000 to around 24,000. There has also been substantial increase in manufacturing licenses too. Being home to many international regulatory approved facilities, the state has displayed its prowess in contract manufacture and research services (CRAMS). Global pharma majors have entrusted the pharma companies here to manufacture many of the leading brands. There has also been substantial investments in Hubli, Dharwad, Raichur (Shilpa Medicare), Mysore (Jubilant Life Sciences - specialty chemicals unit) and Bidar (Sai Advantium).
 
What has been the biggest transformation in Bangalore as far as the pharma sector is concerned and the future of the sector in the city?

As mentioned earlier, pharma industry in the Bangalore has gained international limelight. Some of the notable changes in the Bangalore are the modern and state-of-art plants. The city is the nerve centre for the production of leading drugs. Well-known brands like Crocin, Augmentin, Becosules, Zevit and Corex for leading multinational companies that include GlaxoSmithKline and Pfizer are manufactured at the plants located in and around the city. Biocon in the bio-pharma space has its own Special Economic Zone known as the ‘Biocon Park’.

There are niche players like Vascular Concepts in the stent research and production space. The city has been known manufacturing a wide range of drugs from anti-infectives and neuro-psychiatry. From AstraZeneca, Biocon, Bal Pharma, Cipla, Medreich, Micro Labs to RL Fine Chem adds a distinguished aura to the city. Shilpa Medicare in Raichur, Strides Arcolab and Biocon are engaged in bulk drugs and formulations of oncology drugs. Companies like Micro Labs, Bal Pharma, Biocon are in the production of diabetic drugs. The information technology environment has led to the development of pharma software which creates an efficient environment for smooth operations in manufacture and marketing. The number of corporate hospitals has led to the growth of the domestic marketing operations for many pharma companies and for the pharmacy trade to generate the required revenues. A number of leading blood banks and blood component producing units have also come up.

Overall the momentum of growth and job opportunities has been driven by multiple factors. These include presence of large number of pharmacy colleges; existence  of a vast scientific pool engaged in drug discovery and advanced pharmaceutical technology, advanced research and high quality modern production facilities and clinical research organizations. Therefore, Bangalore is on a high growth trajectory with the domination of pharmaceutical companies of repute.

As the head of the state drugs control department, I also wish to state that our department too has expanded. We have the Central Drugs Standard Organization (CDSCO) sub-office. The Bangalore International Airport will soon have a dedicated pharmaceutical export-import office.

How would IPA Karnataka State branch use this event to attract the much-needed investments ?
We are hoping this event which is expected to attract about 10,000 participants and visitors would result in substantial investments into the state. The Ministry of Commerce has approved a buyers - sellers meet during this IPC and it will be organized through Pharmexcil which is expected to provide a platform for interaction for nearly 30 – 40 country representatives of pharma / regulatory field.
 
How is the state drugs control department gearing up to handle the mammoth event?
The annual IPC event, organized by the Indian Pharmaceutical Congress Association (IPCA) consists of five national pharmaceutical associations. These are the Indian Pharmaceutical Association (IPA), Indian Pharmacy Graduates Association(IPGA), Indian Hospital Pharmacists’ Association (IHPA), Association of Pharmaceutical Teachers of India (APTI) and the All India Drugs Control Officer’s Confederation (AIDCOC). Every year, one of the associations take on the onus to organize the mammoth event. This year, it is the turn of the IPA and being the president of the Karnataka State branch, I was given to take charge as the LOC chairman. Therefore, the state drugs control department per se is not involved in any way to handle the event, except for the fact that a few officers will provide some assistance and not get directly involved.
 
What according to you are the major challenges facing the sector across the country?
The major challenges in the pharmaceutical sector are the availability of trained manpower. The pharmacy graduates and post graduates coming out of the colleges are not yet ready to meet the challenges of the industry. The present syllabus is not job-oriented and therefore we need to look at a change in the course content making it relevant to the present day scenario. There is a need to increase the number of specializations which could cover clinical research, manufacture, quality control, hospital-community pharmacy etc at the post-graduate i.e. M Pharm level. This would make the candidates globally competitive. Qualified pharmacy candidates need to be the ‘masters’ in their line of specialization and not be just ‘jack of all trades’. On the drugs control administration front, there is need for a uniform standard in the working methodology. For instance, there are variations in grades of officers and operational systems. There is need for the Union Government to take a look at it and devise a more consistent system in all state drugs control departments to have a  uniform implementation.

 As the drug regulatory authority of Karnataka, what are the major initiatives taken to enhance the growth of the pharma sector?
We have taken several initiatives. This department has armed itself with 10  officers at State Intelligence Branch at Bangalore and one officer for intelligence work at each of the five regions (Bangalore, Mysore, Hubli, Bellary and Gulbarga), headed by the senior-most officer i.e. Additional Drugs Controller, which is the heart of regulatory operations. Its role is not just limited to inspection but to gather information on the activity of spurious, adulterated and unlicensed dealings in manufacture and sale of drugs / cosmetics. This is as far as enforcement is concerned.

We are also looking to increase the number of posts for drug inspectors and junior scientific officers across the three drug testing labs at Bangalore, Hubli and Bellary. In fact, there has also been a proposal sent to the Karnataka government to increase the number of inspectorate staff considering the Mashelkar Committee, which insists on one inspector for every 200 pharmacy outlets and  one inspector for every 50 pharma companies to be supervised. It is the new labs and the additional enforcement officers that will help to enhance the growth of the pharma sector allowing speedy approvals for granting licenses and issue of drug test reports speedily.
 
Could you provide us with the broad outlines of the pharma policy expected to announce by the state soon?
It would be difficult for me to comment on this as this is a Government decision. All that I can say is that going by the developments so far, the pharma policy would give a further fillip to the sector.

Would you be able to tell us about your initiatives which have revolutionized the working environment not just of the department but of the functioning of the pharma sector as a whole?
There have been around six orders issued by the CDSCO through the Drugs Control General of India (DCGI) to constitute sub-group to deliberate specific issues on the terms of reference of the task force and to recommend appropriate course of action on issues like policy formulation, pricing of generics , computerization, Trace & Track, eradication of spurious drugs etc. Now  for all of these, I have been made a member. But for the Committee on the Amendment of the Drugs & Cosmetics Rules, I have been made the chairman. From a state perspective, the move to go in for computerization across the department, has resulted in on-line issue of pharmacy trade and manufacturing licenses and renewal across the 30 districts which will lead to transparency, integrity accountability and efficiency. These moves on a larger scale have revolutionized the working environment of the department and overall functioning of the pharma sector.

 
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