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Maharashtra FDA beefing up regulatory apparatus

Abhidnya Matwankar
Friday, August 24, 2012, 08:00 Hrs  [IST]

Maharashtra Food and Drugs Administration (FDA), the agency for  enforcing the Food, Drug and Cosmetic Act in the state, is taking a slew of initiatives to strictly implement D&C Act and FSSA Act in the state. Mahesh Zagade, former Pune municipal commissioner, who assumed the charge as  commissioner of FDA last year, in an interview with Abhidnya Matwankar, shares his views on the challenges in enforcing regulations and the need to increase the number of drug inspectors in the state to the desired level. Excerpts.....M_Zhagade.jpg

What are the initiatives Maharashtra FDA is currently undertaking to safeguard public health?
In order to safeguard and enhance public health by assuring safety, efficacy and quality of drugs and cosmetics, we are taking a number of initiatives. Our first initiative towards achieving this goal was  by taking pro-active steps to strengthen the organisation. We have been constantly updating and upgrading our organisational set up by creating posts of joint commissioners and assistant commissioners in both food and drugs departments for strengthening the regulatory infrastructure of the authority.

However after seeing a spate of cases regarding medicines and adulteration of milk, the proper implementation of Drugs & Cosmetics Act, 1940 has become the main focus now. Steps are being taken to strictly enforce the rules and bring to book those who are flouting D&C norms and FSSA norms and rules.

What are the issues hampering the effective implementation of Drugs & Cosmetics Act, 1940 in the state?
The  foremost  need is a change in the mindset. The stakeholders should have more trust in FDA and co-operate with the organisation  for implementing the Act. Right now stakeholders are not fully aware of the provisions enlisted under the drugs and Cosmetics Act. So one of our key focus areas will be in addressing  this important aspect so as to make citizens, stakeholders and manufacturers more aware of their responsibility and requirements.

Do you feel that the selection process of MPSC is transparent and give full justice to the recruitment rules?
Maharashtra Public Service Commission (MPSC) is an independent body which provides suitable candidates to various government posts and advise them on various issues like formulation of Recruitment Rules (RR).

Since, we have felt the need for changes in recruitment rules of FSSA as well as the need for more inspectors, we have suggested changes and have sent proposal to the state government requesting more drug as well as food inspectors. Whether our proposals will be accepted is according to the discretion of the Govt.

What are the major functions of a drug regulator?
A drug regulator needs to focus on implementation of law. If the desired objective of law formulated is not achieved, he must review the machinery available for the implementation of law. He should constantly empower himself through training to ensure accountability. Most  of the problems  occur in its absence.

The drug regulator should also strive to improve functioning of laboratories, equipment, process and software. Since much of the processes are carried out in laboratories, the functioning of laboratories should be constantly upgraded. At present we are striving to strengthen the sampling analysis mechanism.

What are the steps contemplated to ensure the presence of pharmacists in the chemist shops?
A pharmacist is important for dispensing of medicines and also can act as a counsellor to a patient. As per the Drugs & Cosmetics Act (D&C Act) , it is mandatory that a pharmacist should be present in the chemist shop all the time. But somehow this is not being strictly followed. We are planning steps to ensure proper implementation of the law so that chemists shop will have registered pharmacists without which their licences will be cancelled.

Maharashtra was numero uno in terms of pharma production. Has it lost the sheen compared to other states now?
Maharashtra contributes substantially to the pharmaceutical sector. Most of the drugs and pharmaceuticals produced in the country are manufactured here. We have the maximum number of active pharmaceutical ingredients (APIs) units.

Maharashtra had been numero uno in pharma production. The state leads in exports with a share of 40 per cent of the India’s pharmaceutical market with a manufacturing strength of 29.7 per cent (in 2008-09).However it lost some of its lustre due to the tax benefits offered by many other states. It would definitely regain its numero uno status if proper incentives are offered to the manufacturers.

Currently how many drug inspectors are posted across the state? Is FDA planning to to appoint more drug inspectors?
The sanctioned number for Drug Inspectors (DIs) in the state  is 161.Presently we are having only 131 DIs which is not sufficient to keep vigil  on all the pharmacists across the state. But in future we are planning to have 1000 DIs in the state.  We have already send the proposal the state government for increasing the number of DIs.

What are your comments on the steps to monitor sub-standard drugs?
Monitoring of drugs  has to be undertaken round the clock. Drug Inspectors are responsible to keep a check on each and every chemist shop, doctors, pharmacists etc. We are coming up with the rigorous implementation of D&C Act in the state to stop the illegal sale of drugs.

Recently the sensitisation drive to check the misuse of abortion drugs was undertaken. How many retailers, wholesalers and pharmacists are  found flouting the norms of D&C Act?
We have started inspecting all chemist shops across the state for monitoring the sale of drugs and medicines used for termination of pregnancy within 63 days. Our focus is to stop the sale of abortion kits.

We are keeping a close tab on the sale of the drugs and are also taking strong action against chemists and dealers.

We have scrutinised all the data till now and have lodged 29 FIRs in the state. Among these 16 are doctors which includes BHMS, BAMS, MBBS doctors. We also found 547 doctors, 2793 retailers and 665 wholesalers flouting the norms of D&C Act.

How is FDA  sensitising consumers while buying medicines over-the-counter?
We have asked Drug Inspectors to reach out to the masses and  carry out sensitisation drives to help patients in buying right medicines with doctors' prescription and most importantly pharmacists being present at the shop.

We also want medical fraternity and various other departments to come together to conduct mass awareness programmes amongst people of not only rural but even from urban areas to make them aware that they should buy medicines with proper doctors' prescription and not to buy medicines own  their own.

What are the FDA plans for opening  food and drug laboratories across the state?
We have send proposal to the state government to set up nine food testing labs, five drug testing labs and 37 mobile labs in different parts of the state. The total cost of establishing these laboratories is estimated at Rs. 850 crore.


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Ilango ira Oct 16, 2012 12:35 AM
Thought provoking interview
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