The Maharashtra state Food and Drug Administration (FDA) is a pioneer in introducing pro-active drug regulatory methods in India. The office is well appreciated by the regulatory experts for prompt implementation of every new decisions taken in by the central drug control mechanism. Besides, the FDA has also led up nationwide discussion on various regulatory issues related to control of nutraceutical products with curative claims and the standard of drugs used in medical devices like drug eluting stents. The FDA is currently going through an office modernisation programme. In an interview to Chronicle Pharmabiz, Dhanraj Khamatkar, Commissioner, FDA elaborates the efforts carried out by the office to improve the drug regulatory environment in the state. Excerpts...

Maharashtra FDA is well known for its pro-active drugs regulatory activities. What are the unique achievements of the state authority when compared to the other state drug regulatory authorities?
Independent food wing and drug wing with the infrastructure of the competent officers to enforce the food and drug laws are the main strengths of the FDA.

In addition to this, we have two modern and self-sufficient drugs control laboratories at Bandra and Aurangabad. These laboratories have the capacity to test and analyse around 8500 samples of drugs and cosmetics per year.

Maharashtra is the only state in the country whose FDA have decentralised the licensing of the drugs manufacturing activities. In addition to this FDA have separate offices at each district of the state.

Could you elaborate the current status of modernisation of FDA office?
The FDA is the first drug control administration in the country which initiated the computerisation of the entire working of its drug wing. Today the reporting of the drugs samples testing is completely computerised. The drugs control laboratory at Bandra is the only government lab which is NABL accredited. Currently, we are in the process of computerisation works in the food wing.

The standard of FDA's drug testing labs is much acclaimed by national and international authorities. Could you brief us on the future expansion (upgradation) plans of the labs?
We are in a process of upgradation of both the drugs control laboratories at Aurangabad and Bandra.

The FDA is known for its efficiency in tracking down spurious drugs in the state. What are the special measures taken to curb spurious drugs in the state?
We have independent intelligence branch headed by the senior IPS officer as joint commissioner [vigilance] assisted by assistant commissioner-intelligence branch and a team of drugs inspectors at headquarters and each divisions.

The intelligence branch performs the detection and investigation of the clandestine activities in the field of manufacturing, storage and sale of drugs.

What is the current status of FDA's efforts to increase the staff strength? What is the status of the recommendations by the FDA panel to the High. Court in this regard?
Recently, all the vacant posts of the food wing are filled. We are in a position to cater the needs of strong enforcement of the food laws. Similarly, the process of filling the vacant posts of 96 drugs inspectors and 15 assistant commissioners for drug control is in progress. Hence, in the near future both the wings will work with full strength.

Of late, the FDA has initiated several special campaigns to ensure quality of specific therapeutic and non-therapeutic segments (cosmetics and drugs in dispensaries). How far the campaigns help the authority to keep track on these segments?
In routine course of working we collect and test around 8500 samples of drugs and cosmetics per year in the state. The appropriate actions like administrative or legal are taken against the manufacturers whose samples do not comply with the laid down standards.

Drugs & cosmetics samples tested by FDA in last three years

[Administrative actions like suspensions/cancellation of licences are taken in all cases]

In addition to this, around 560 samples were drawn and tested in 2006-07
as per the directives of the High Court, Bombay. Out of this, 51 samples were found not of standard quality. The appropriate administrative actions were taken in all cases.

The special drive of the cosmetics samples was conducted in April 2008, wherein 125 samples were collected in the state. Out of this, 21 samples were found to be of spurious nature. In the matter of spurious samples, the investigation along with the police is going on and the prosecutions will be launched in the matter.

Could you elaborate the programmes of FDA to equip itself to regulate the fast developing pharmaceutical industry?
We always take optimum efforts to keep officers and staff well equipped with modern and recent technical, legal and managerial skills by way of continuous training activities.

FDA's recent sampling showed that a large number of substandard drugs are entering into the state from the North Indian states like Baddi. Could you give us a brief idea about the course of action to prevent the inflow of substandard drugs to the state?
FDA publishes monthly list of not of standard drugs with the purpose to prevent the use of these drugs by the consumers. These lists are circulated to all the govt. and semi-govt. hospitals, trade associations, consumers associations etc.

In addition to this, the administrative and legal actions are taken against the manufacturers concerned. In the cases of samples manufactured by the manufacturers in areas like Baddi and other places, the matters are reported to the concerned drug control authorities for necessary action. The stocks of such drugs are recalled and sent back to the manufacturers.