Karnataka drugs control department functions in an environment of transparency and efficiency. Today, the department is manned by 51 inspectors, 38 assistant drugs controllers, 8 deputy drugs controllers and one additional drugs controller. But holding the mantle of the state drugs regulatory authority is Dr. B R Jagashetty, who has driven the need for   computerization, speedy clearances of manufacturing - pharmacy trade licenses, disbursing of quick test reports and ensuring streamlined operations across the offices located across the state. In an interaction with Nandita Vijay, Dr. Jagashetty indicates the issues and the future focus areas of the drugs control department, Excerpts:


As the Karnataka drugs controller, member of the DTAB and chairman of Committee on the Amendment of the Drugs & Cosmetics Rules, how do you react to the current controversies embroiling on the DCGI appointment?

I would refrain from commenting on these issues as they do not come under my purview.

Do you feel that the selection process was transparent and do you feel full justice was done to the Recruitment Rules?
Actually, it would be difficult to comment on the same as the matter is sub-judice.

There were many contenders to the post from the state drugs controller space, do you feel that the Ministry of Health could have opted for candidates with experience to administration and approval of drugs from the dedicated state departments or selected an incumbent from the office of the DCGI?
It would be difficult to say anything as the matter is before the Supreme Court. Therefore, a  discussion on the same is not entertained by law because it would impede the process of Court proceedings.

What is the impact on the clearances of proposals and files sent in from the state drugs department to a DCGI who has no prior exposure to such assignments?
As of now no problem and as far as our department goes all clearances of proposals and files sent in from the state drugs department to a DCGI are approved on time.

Ministry of Health is now making efforts to strengthen its drug regulatory structure. To this end, it has received proposals from pharma industry to attract Indian officials working at US FDA among other global regulatory agencies on similar lines that of China. Please comment?
While we appreciate and welcome all efforts to strengthen the drug regulatory structure by the Ministry of Health, we have not received any official communiqué to this effect. But such an endeavour is a step in the right direction as it would provide an impetus to the pharma and biotech industry. However, Indian officials working in the US FDA are welcome to train us provided the government permits.

What are the major issues and challenges for a drug regulator?
The key issue before a  drug regulatory authority today is to ensure that the good quality drugs at prices decided by the government of India are available to the common man. As indicated in my earlier discussions, 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 a need to take a look at it and devise a more consistent system in all state drugs control departments. But to deal with the shortage of  manpower, I feel it depends on the mindset of the officer in-charge of the department where he will need to judiciously delegate the work among the existing staff.

What is your quick remedy for a streamlined and efficient regulatory system in the country?
No comments from a country perspective except for the fact that transparency and accountability are cornerstones to strengthen the regulatory framework. But from a state drugs department angle, I wish to state that streamlining the licensing approvals online have been a big relief for both the pharmacy trade and the pharma industry. We also embarked on the short message service (SMS) to the pharmacy outlets owners in the state to provide the details on the clearance of applications submitted to seek fresh licenses or renewals. Karnataka is the third state in the country to adopt the electronic mode for issue and renewal of licenses after Gujarat and Maharashtra. This is a major effort to streamline operations and bring in the much-needed transparency. The computerization and networking of the  drugs control head office in Bengaluru has helped to monitor every file and the process which comes in for clearance. This would help lead to better patient protection through provision of medicines which are safe, efficacious and good quality.

You have been the drug regulatory chief of Karnataka for the last four years (from May 1, 2008), what are the most important programmes undertaken by the department to increase the prospects of the pharma industry?
It is undoubtedly the computerization of the department which has helped the end-users to save on time and increase efficiency. It is creating a paperless environment with no duplication. There are speedy approvals and the ability to track the files for the department  across the 30 districts leading to  transparency, integrity accountability and efficiency. These moves on a larger landscape have transformed the functioning and overall performance of not just the state drugs control department but the pharmacy trade and the pharma industry.  Another one is the pharma policy which is receiving its final touches from the department of health and family welfare.

Your department under your tenure has gone through a transformation. In your view  which of the moves have given the department an edge in terms of creating a right work environment?
The establishment of the two Regional Drug Test Laboratories at Hubli and Bellary in addition to the existing one at Bengaluru has helped to analyze the drugs sampled  to assess the not-of-standard quality. The department has an Intelligence Cell which is the core of regulatory activities. Its role is not just to limited to inspection but to gather information on the activity of spurious, adulterated and unlicensed dealings in manufacture and sale of drugs. We have five inspectors, at head office and one each in-charge of regional jurisdiction of Bengaluru, Mysore, Hubli, Bellary and Gulbarga to oversee the 30 districts.

How are the five services of the your department which are part of the new Karnataka Bill ‘Sakkal’ to provide guarantee of services to its citizens faring?
Specific to this department, the guarantee services are for  grant of licenses, renewal of licenses in pharmacy trade which will need to be completed within 30 days, change of qualified candidate at a pharmacy retail outlets, competent person manning wholesale drugs business,  name change  for firm  or company of a pharmacy outlet for which  time duration is  one week. If the time lines for these tasks are not met then the concerned officer of the licensing authority would have to  pay a fine of Rs. 20 per day. Every designated officer now provides the service within the stipulated time which begins  from the date when required application for scheduled service is submitted. During the month of  June so far,  534 applications have been cleared and none are pending proving the  officers’ level of responsibility  and accountability. As soon as applications are received automatic SMS is generated to the  applicant and  similarly when it is dispatched.

Finally, Karnataka is all set to unveil its pharma policy and a separate State Drugs and Cosmetic Rules under the Drugs & Cosmetics Act 1940 which now places the state regulatory office as a mature authority displaying not just capability but competence.  Could you please provide us details on the reasons for a Policy and the Act and what is the reason for the latter as wouldn’t this replicate existing D&C Act?
Yes, the Karnataka Pharma Policy will boost industrial growth, seek to attract investments and increase employment opportunities. The separate State Drugs and Cosmetic Rules under the Drugs & Cosmetics Act 1940 will look at methods to further augment the monitoring of quality of drugs and ethical trade practices in the state. It will no way duplicate the Drugs & Cosmetics Act 1940 and Rules 1945. But the state rules will help to plug loopholes to bring the offenders to the book of law.