There are very few parallels for the Food and Drug Administration (FDA) inthe state of Maharashtra. Over the years, the state FDA has remained a trend-setter through introducing novel ways in efficient drug administration. It claims many firsts to it credit that will enable it as a model functionary to sister states.
Maharashtra FDA is probably the only drug regulatory authority in the country that will have the distinction of training international drug regulators. So far it has been approached by neighbouring countries like Bangladesh and Afghanistan for training their drug regulatory personnel
According to highly placed FDA officials, the institution is expecting training requests from other SAARC countries, African, East European and South East Asian countries.The training is mostly on the fronts like spurious drugs activity monitoring, drug testing, and site inspection.
On the domestic front Maharashtra has been providing training to inspectors in states like Uttar Pradesh, Bihar, North Eastern states, Tamil Nadu, Andhra Pradesh and Karnataka, said senior FDA officials.
"The quality of FDA's drug testing infrastructure being high, IDMA usually recommends our labs to the visiting delegates. Recently, a Ukranian pharma delegation had visited our labs to check the quality of our drug testing and were quite satisfied with it," says S W Deshpande, joint commissioner, Vigilance, Maharashtra FDA.
The state FDA has a well-equipped laboratory which has a present capacity 6000 samples per year. An additional laboratory has also been set up at Aurangabad. The drugs control laboratory has facilities to test different categories of drugs like chemical, biological etc.
The state of Maharashtra grabs a big chunk of the Rs 20,000 crore Indian pharamaceutical industry. Nearly 4000 out of the 20, 000-odd units in the country are located in the state. Their contribution to the annual turnover is approximately Rs. 8000 crore which is 40 per cent of the total turnover. Out of top ten companies, four companies and corporate offices of the leading companies are located in Maharashtra.
The Drugs Controller of the State of Bombay was established way back in 1947 under the surveillance of the then Surgeon General. On 15th November 1959, independent Drugs Control Administration headed by the Director was formed. Today, after more than five decades, the state FDA with presence even in the remote parts of land is able to effectively monitor and ensure the quality of food and drug meant for human consumption.
Maharashtra is the first state to adopt integrated approach as regards to monitoring the quality of both food and drugs. In 1970, Directorate, Drugs Control took over the responsibility of implementation of the Prevention of Food Adulteration Act, 1954 and the name of the department was changed from Drugs Control Administration to the Food and Drug Administration, Maharashtra State.
"FDA Maharashtra aims to ensure transparency and speedy delivery through well-defined priorities and methodology. It stands for equal treatment to all,'' says Deshpande. It has issued a 'Citizen's Charter' for the benefit of the existing and prospective manufacturers and distributors of medicines and consumers. The requirements for grant or renewal of licences the methodology adopted and the grievance redressal system is clearly spelt out in the 'Citizen's Charter'. FDA has also issued elaborate written guidelines for the benefit of licensing authorities and field staff to eliminate variations in interpretations and procedures. Specific time limits are also prescribed in the guidelines so that the applicants get the required certificates/ licences speedily and in specified period.
Plan Approval: The prospective applicants are required to submit the plan of the proposed manufacturing unit before the application for grant of licence can be submitted. The applicant is advised on the selection of location, plan layout so as to ensure logical and uni-directional flow of men and materials. The plan is scrutinized by the panel of experts comprising senior Assistant Commissioners and finally the plan is approved by the licensing authority.
Site Inspection: Site inspection is carried out once the factory premises are constructed as per the approved plan. The applicant is also advised during this visit about the requirements in respect of plant, machinery and equipment.
Product Approval: The formulations are approved on the basis of therapeutic rationale and stability studies. The products are approved in consultation with the technical officer.
Post Licencing Monitoring: The extent of compliance of Good Manufacturing Practices (GMP) and the licensing conditions is checked on regular basis through periodic inspections. Based on the findings during the inspection, measures such as directing compliance or penal action such as suspension or cancellation of product permission or licenses is taken.
Post Marketing Surveillance: The quality of products ready for release and placed in the distribution network is monitored by way of drawing of samples at the manufacturers premises and at distribution outlets. Suitable administrative or legal action is taken on the basis of the government analyst report declaring a drug to be not of
standard quality.
Drug Recall: Effective recall of a substandard drug is ensured by directions to withdraw issued to the manufacturer. FDA Maharashtra is the first state to formulate guidelines for effective and quick recall of products declared to be substandard which includes giving wide publicity to alert the consumers about the drugs declared to be sub-standard and circulating the list to trade associations, Govt. and semi-government hospitals. Other state drugs controller and also alerted on substandard drug.
Major Initiatives: The government of Maharashtra amended the principal Drugs and Cosmetics Rules, 1945 and came out with the Maharashtra Drugs and Cosmetics (First Amendment) Rules, 1995. Decentralised powers for grant of manufacturing licences under the Drugs and Cosmetics Act, 1940 and for grant of consent to launch prosecution under the Prevention of Food Adulteration Act, 1954. The state FDA has also developed Management Information System and Monitoring System and modules such as Drug Control Laboratory Management System Drug Management System Personnel Management System, Stores Management System etc., have been developed and are being implemented. These are currently under various stages of implementation.
Curbing Spurious Drugs: FDA Maharashtra has a fairly good track record in tackling spurious drug manufacturing and counterfeiting. According to Deshpande, ``Spurious drugs incidence are not very common in Maharashtra. Still, I can't say there is none. But the menace is effectively tackled by instantaneous intervention by the alert FDA officials.''
The state FDA has an independent intelligence branch comprising five Drug Inspectors and three Watchers. The Assistant Commissioner, Intelligence Branch, heads the branch. The Intelligence Branch investigates cases mainly on the basis of intelligence gathered by the officers through their informants. There is a system of issuing rewards to the officers and incentive to the informants. Realising this as a success a few other states have also established such separate intelligence branches.
Maharashtra FDA champions organising a number of campaigns. In a effort check the uninterrupted medical practice by unregistered or bogus practitioners, the FDA has recently launched campaigns throughout the state. However, the campaign put bogus practitioners in the alert gear and the vigil could catch much quakes in its net
It also conducted a campaign on companies selling their drugs at higher than the ceiling prices prescribed by the NPPA. However FDA has stalled its scrutiny for the time being as the matter is now under judicial supervision.