R P Meena IPS, took over charge as the Director General of Drugs & Copyrights, DCA, Government of Andhra Pradesh in 2007. Since then he has been playing an active role in strengthening the drugs control administration. A dynamic police officer in the rank of ADGP, he has effectively enforced the Drugs and Cosmetics Act & Rules in a state where more than 1800 pharmaceutical companies, including bulk drugs and formulation majors and about 50,000 medical shops are working. He has also engaged an NGO called ‘Private Watchers’, to assist the enforcement agencies in a special survey to tackle the menace of spurious and substandard drugs. Excerpts from an interview with Peethambaran Kunnathoor .
After being posted as the Director General of DCA of Andhra Pradesh three years ago,what are the measures you have taken so far to strengthen the drug control administration?
This was in fact a neglected department earlier. In 1976, when a separate department was created for DCA, there was only one director, two joint directors, two deputy directors, eight ADCs and 55 drug inspectors. This situation continued up to 2007.
Currently all the 23 districts in the state have separate licensing authorities. Each district has a ADC with licensing powers. With two more additional ADCs, one in Hyderabad and one in Rengareddy district, there are 25 licensing authorities in the state for medical shops alone.
Now licence is issued with in 48 hours. Four licensing authorities, including a director, are dealing with the manufacturing industries and one joint director has been posted to look into the cases of blood banks.
The number of ADCs has been increased to 29, two additional posts of joint directors have been created for enforcement, the number of deputy directors was increased from two to eight , and 75 posts of drug inspectors have also been created for the convenience of the public. The process of further recruitment of 106 drug inspectors is in progress. All these happened after a period of 32 years of the creation of the department. It is a history.
Which are the other areas you have given priority?
The government has immensely supported and helped all my endeavours to strengthen the department to provide good services to the poor people.
The existing two testing & analytical laboratories at Hyderabad and Vijaywada have been strengthened with the government’s aid under DFID. Measures are being taken to increase the capacity of sample analyzing and reduce the reporting time to 30 to 45 days from the present time of three to six months. Soon the two labs will be able to analyze 25000 samples per annum in place of the present 3000. Further, we are planning to set up four more regional labs.
Andhra is regarded as the hub of pharmaceutical industry in the country, especially in the case of bulk drugs. What steps you have taken to improve the industries?
The state government and my department are industry friendly. We are doing the maximum help for them. We want those companies shifted from AP to Himachal Pradesh and Uttarakhand to come back to our state. It is because of the initiative of the former Chief Minister Rajashekara Reddy, the Union Govt reduced the excise duty from 16 per cent to eight per cent. He used his good office in favour of pharma industry.
Now, Andhra Pradesh Industrial Infrastructure Corporation (APIIC) allots lands on cheaper rates to companies who wish to start their units away from the city.
In Madhapur area, the APIIC has allotted lands less than 50 per cent of the market rate.
In Jadcherla in Mehboobnagar district, government has allotted lands at a rate of Rs 5 to 8 lakh per acre through APIIC. In that area, the market value for one acre ranges from Rs 50 to 60 lakh. Aurobindo has got 60 acres and Hetero has purchased 60 acres there. Both the companies have set up their R&D divisions and formulation plants there.
A separate pharma city has been created in Parwada Taluk of Vishakapatanam where thousands of acres of land were placed part of Pharma City. The Bangalore based Bicon got 60 acres there. It is just to overcome the environmental problems in Hyderabad, the pharma city was shifted to other place. In other ways, the units are shifted to their safer areas. Our department is guiding them as the department is industry-friendly. We also want our cities free from environmental hazards.
How many companies have gone to north India ?
They have actually migrated. Their presence is here also. Only 60 formulation companies have migrated to HP and to Uttarakhand. Now they are coming back.
What are the other assistances provided by the government to help the pharma industries?
We are giving subsidy for power, water and for import of raw materials. Measures are being taken to develop the export facilities. In Vishakapatanam, the airports are being expanded.
Further the state financial corporation is arranging loans on reasonable rate of interest to the companies.
How do you rate the performances of the pharmaceutical Industry in your state ?
They are all doing well. As I said, Hyderabad is the hub of the pharmaceutical industry in India. Besides the job potential, the government is getting very good revenue from these firms. More than Rs 3000 crore are coming to government treasury in the form of Income Tax, Sales Tax and VAT. Out of the total exports from India, 30 per cent is from AP.
Earlier, only big companies were manufacturing bulk drugs, now small companies have also started manufacturing. Even in the recession period, APIs were growing in the state and the industry’s turnover was increasing.
Apart from the bulk drugs and APIs, how do the pharmaceutical majors in the formulation segments fare?
The state has a total of 800 companies, including formulations and APIs. Certain companies have several special units for APIs. For example, Dr Reddy’s Lab has six units for APIs, Hetero has seven , Aurobindo has seven , Matrix Lab has eight . All these firms have separate formulation units also, but we consider them as one.
Andhra Pradesh is having the largest number of pharmacy colleges in India. What do you feel about the interaction between the industry and academic institutions here ?
There are 280 pharmacy colleges in our state. Out of these, three are managed by Government. All these colleges are supplying manpower to the companies. Andhra Pradesh is the biggest contributor of HR to the companies and CROs. Besides, the state has a lot of hospitals, hence there is a very good patient pool is in the state. So there is vast scope for conducting clinical trials.
We are planning a programme under which there will be direct interaction between the industry and the academic institutions.
How does the government help the pharmacy colleges in the state ?
Andhra Pradesh is the only state in India giving fee reimbursement and scholarships for pharmacy courses. From Diploma to Pharm D, fee is given for the poor and backward community students. Now the government has decided to disburse the entire amount due for the colleges in respect of reimbursements. Near about Rs 50 crore would go for the pharmacy colleges on behalf of students’ fees.
What are your future projects and plans ?
The department has requested the government Rs 12 crore under DFID for strengthening the existing two laboratories. Both the labs at Hyderabad and Vijaywada will have new buildings with a plinth area of 1500 squire feet. Further we are planning to set up four regional labs. They will be established at Warangal, Vishakhapatnam, Vijaywada and Karnool.
There are 20 approved private labs in the state. Government is thinking to give accreditation to the labs soon and steps are being taken for it.
I have also written to the government to consider free power supply to the medical stores like that of in the agriculture sector. The Chief Minister has responded positively to my request
What is the status of blood banks in the state ?
Currently there are 231 blood banks in AP. Further there are 85 blood storage centres functioning. Regular inspections are being carried out in all these units. Within last two months, 300 samples were taken and tested.
Out of the 231, 66 units are government controlled blood banks, 36 are managed by Red Cross Society, 53 are run by voluntary and charitable organizations and the remaining 76 are owned by private hospitals.
As on May 30 this year, the number of stop production orders issued to blood banks is eight, not functioning blood banks are five and the number of blood unit not available is 16.
In Tamil Nadu, recently there was an issue of recycling of expired drugs by some distributors and the cases are now investigated by the CB-CID. Some of the arrested persons confessed to the police that they got the drugs from Andhra Pradesh. How do you react to this ?
There is no case of expired drugs emerged in Andhra. If Tami Nadu police or Drugs Control Department has the case, let them give us in writing. We will enquire about it.
How far your private force –‘private watchers’- has succeeded in helping the enforcement agency to conduct a state- wide market survey ?
The private people’s involvement in the survey has helped a lot for an authenticated study. They lifted a total of 5261 drugs samples during 2008-2009 and 2009-2010 periods from rural and backward areas. Out of these 5261 samples, only 57 were found Not of Standard Quality (NSQ), which came around 2.91 per cent that was far below the national average. This was the most authenticated survey conducted by the department which is an example in the whole country.
What action was taken against the violators ?
As on today, there are 1117 cases pending trial in different courts. So many companies were charge-sheeted. During the last two years, 75 cases have ended in convictions and in the last three years, as many as 190 seizures were conducted during raids. Drugs worth about Rs 11 crore were seized during this period. I think this is a significant development.