The Maharashtra Food and Drug administration (FDA), head-quartered in Mumbai, which had been in the news for taking head on the ongoing pharmacy trade cartelisation and implementing the practice of pharmacy for public safety, has recently taken several steps to spruce up monitoring and inspection of the sales establishments under the Drugs and Cosmetics Act, 1940.
In a move to strengthen regulatory mechanism, the state regulator established in 1959, has also constituted a 11- member executive committee for formulating specific guidelines for the Rx or prescription of drugs in the state for ensuring compliance of regulatory requirement.
Strategy to expedite inspection
In order to achieve more transparency in the functioning of chemist shops across Maharashtra, the State FDA has also devised a new strategy to streamline the process of monitoring and inspection.
Under the new strategy , the drug inspectors have been directed to conduct inspections based on specific parameters which take barely 15 to 20 minutes. The earlier practice of conducting detailed inspections used to take at least two to three hours which was time consuming.
Under the inspections based on specific parameters, the drug inspectors have to inspect whether the chemist is having the license, verify the presence of a qualified pharmacist in the shop and whether proper purchase bills are maintained by the chemist.
The new strategy has yielded good results. The fact that out of the total 67000 pharmacy outlets in the state, around 47, 000 units could be inspected in the year 2012-13 compared to only 19,000 in the previous year stands as a testimony to this.
As this system of monitoring has shown good results, it can be a model which can be replicated in other states as well. "Whenever license to the manufacturer or trader is granted, it is mandatory for the licensee to comply with 18 to 20 conditions under the detailed inspections category," explained D R Gahane, Assistant Commissioner (HQ), FDA. This system is all the more relevant considering the fact that there is a business of medicine supply worth Rs 17,000 crore in the state.
Billing inspections
State FDA has also embarked on an action plan to implement 100 per cent billing inspections on thousands of pharmacy outlets spread across the state. This according to FDA officials will help in the recall of products which are not of standard quality and also help to trace products with adverse drug reactions (ADRs).
Though 50 per cent of the state's sales establishments, mostly located in the interior parts of Maharashtra, still face the challenge of implementing the electronic system of issuing bills due to lack of know how, intermittent power supply and other technical issues, the plan has seen the light of the day in all metros and districts.
According to a senior FDA official, Rule 65 of the Drug and Cosmetics Act mandates that the retail licensee should issue the bill in compliance with the acts related to it. Having an electronic facility of bar coding provided by the retail licensee ensures that manufacturing date, expiry date, batch number and other relevant details are checked for the sake of authenticity.
The mandatory exercise of issuing bills is governed by Drugs and Cosmetics Act, 1940, Drug and Magic Remedies Objectionable Act, 1954, Drug Price Control Order, 2013 and Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS) Act.
"Issuance of billing can be successfully implemented through routine inspections and sensitizing wholesalers and medical practitioners" says Jayant Yadav, secretary, Drug Inspectors Welfare Association.
Online WHO GMP certification system
Ever since the Maharashtra FDA introduced the online WHO GMP Certificate Generation System in August last year, there has been a considerable increase in the filing of applications for the WHO GMP certificate and its disposal.
“The success of this system can be assessed from the fact that there is an increase of around 72 per cent in the receipt of applications and around 47 per cent increase in the disposal of the application when compared with the manual process of disposing cases," informs Dr Rakesh Tirpude from State FDA.
The state FDA had introduced the online WHO GMP Certificate Generation System for the purpose of export registration in 210 WHO member countries last year. Since then, the pharma exporters have been able to minimize their efforts for applying, processing and scrutinizing the applications in a transparent manner through a standardized procedure. This has not only led to an increase in the revenue collected by the administration but also exports of pharmaceuticals from the state, FDA officials said.
India boasts of the maximum number of WHO - GMP certificate holders with the Maharashtra FDA granting a large number of certificates considering the quantum of export of medicine to foreign countries.
According to the state FDA Commissioner Mahesh Zagade, the ultimate aim of the regulatory body is to achieve public health and safety with the help of these strategies and exercises. State FDA functions under the administration of 150 drug inspectors and 30 Assistant Commissioners. Though public safety is the main objective of the agency, the thrust lies on deterrence administration which warrants exemplary action for an offence, points out Zagade.
In order to make the manufacturing units accountable and manufacturing process robust, they need to be thoroughly inspected once a year with focus on quality by design rather than quality by testing, he concluded.