The Maharashtra FDA has carried out 23,145 inspections during the financial year ended March 2006 and it has collected 7597 samples for the inspections with the help of 81 inspectors. In the first quarter of the current year, FDA has undertaken 5056 inspections and it has collected 1664 samples. FDA has taken action against 20 drug manufactures, during this period. Besides it has also cancelled 29 drug licences.

Speaking with pharmabiz, Amitabh Chandra, Maharashtra FDA, said, "Maharashtra is the first state, to adopt integrated approach as regards to monitoring the quality of both drugs and food".

"We will take strict actions against non compliance of Schedule-M by the drug manufacturing units. However we are considering their efforts towards implementing Schedule-M guidelines, Currently we have strength of 119 drug inspectors, but we need to appoint around 55 drug inspectors in short period. Due to the shortage of drug inspectors, the existing staff is under tremendous pressure", he further added.

FDA Maharashtra aims to ensure transparency and speedy delivery through well-defined priorities and methodology. It stands for equal treatment to all.

The FDA is approving the formulations on the basis of therapeutic rationale and stability studies. It is also monitoring compliance of Good Manufacturing Practices (GMP) and the licensing conditions are checked on regular basis through periodic inspections. The FDA is taking, measures like penal action, suspension or cancellation of product permission and licenses.

The FDA Maharashtra is the first state to formulate guidelines for effective and quick recall of products from the market. If the product found to be substandard, the FDA is giving wide publicity to alert the consumers and circulates list to trade associations, Govt. and semi-government hospitals. It is also informing other state drugs controllers.