The Andhra Pradesh Drugs Control Administration (APDCA) has been working tirelessly to weed out default drug manufacturers, check unregistered pharma stores and to contain spurious drugs in the state.
Apart from conducting regular check-ups, the DCA is also offering services like providing information about licensed blood banks, banned drugs and prices of notified drugs, register complaints relating to services of chemists and druggists and check quality of drugs and adverse reactions caused by any drug in the state.
In addition to these regular services, the DCA is also entitled to grant and renew drug manufacturing licenses, approval for setting up of new laboratories, issue of WHO GMP certificates, fresh sale certificate, market standing certificate, production capacity certificate and renewal of sales license etc.
The main function of the DCA is to ensure implementation of various laws enacted by the Indian government to protect citizen’s rights with regard to safety and health security. It ensures that Drugs and Cosmetics Act, 1940 and Rules made there under are strictly adhered to.
Apart from this, DCA ensures that the Drugs (Prices Control) Order, 1995, the Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954, and the Andhra Pradesh Narcotic Drugs and Psychotropic Substances Rules, 1986 are enforced to protect and maintain a safe and secure drug manufacturing, supply and sale regime in the state.
After the completion of tenure of earlier DG R.P Meena, the government of Andhra Pradesh had appointed R P Thakur IPS, as the new Director General of Drugs & Copyrights, DCA, in the state.
Recently Thakur, a dynamic personality, always dedicated and focused on achieving goals, received the ‘president’s police medal’ for his distinguished services in the police department.
Thakur has earlier served as Additional Director General of Police, Technical services. Within a short span of just 10 months time Thakur, has taken up many challenging issues and have resolved many of the pending issues regarding drug regulations and many more are on the verge of getting settled with the co-operation of the pharma industry in the state. There are more than 1800 pharmaceutical companies, including bulk drugs and formulation majors and about 50,000 medical shops in the state.
As Andhra Pradesh is already known as one of the top pharma hubs in the country, especially in the bulk drug arena, the state has performed remarkably well over the past few years. While more and more pharma companies are planning to set up their bases here, there are a host of problems and industry related issues that are to be sorted out by the Drug Controller which could attract more investments to the state. Hence the most important priority for the new DG now is to further strengthen the drugs control administration in the state.
A major area of concern for the DCA is the problem of counterfeit drugs. With more counterfeit drugs entering the market, it has become a big challenge for the drug control administration to identify the spurious drugs. There is a need for identifying spurious and substandard drugs and put a ban on them forever. During the past few days, many companies which were producing fake and ineffective pesticides and affecting the poor farmers in the state have been banned by the drug controller.
Recent activities of DCA
Taking forward its initiatives to check spurious drugs the DCA conducted raids on all the retail and corporate pharmacies in the state and found that more than 70 per cent of the pharmacies are operating without registered pharmacists and do not issue regular bills to consumers.
The raids were conducted by DCA as a part of its special drive to check the functioning of registered pharmacists in the state. The Drug inspectors and other DCA officials found various irregularities by many medical stores and issued notices to them especially on issues such as the absence of the registered pharmacists and for selling outdated drugs at the stores.
Corporate pharmacies like Apollo, Hetero Pharmacy, Medimart and Medplus were also raided and booked as many as 281 cases against the medical shops.
“We have conducted the raids as per the rules and as per Drugs and Cosmetics Act, 1940 (DCA), the Drugs and Cosmetics Rules, 1945 (DCR). Many are not complying with the rules and acts as mentioned while issuing the license”, says a DCA official.
Based on the complaints, the DCA has acted on the pharma stores and brought to light many irregularities. About 406 retail medical shops throughout the state were raided and out of these 281 retail medical shops were found selling medicines in the absence of registered pharmacists and without bills.
“In our raids we have noticed that registered pharmacists were not available at many retail pharmacies. So, the DCA inspected over 406 retail medical shops, including retail outlets of corporate pharmacies. Out of these, 281 medical shops were found selling medicines without pharmacists or without bill,” Said R.P.Thakur, the DG of DCA, Andhra Pradesh.
"We have even found some expired drugs are being sold without bills and we have checked all these aspects in while raiding the shops”, Thakur said. In addition to issuing show cause notices, the shops will be closed for one week. If the same violation is repeated, we will cancel their license," he said. Every shop should have a pharmacist, which is one of the clauses while issuing license, he added.
All the licensing authorities and assistant directors were directed to issue show cause notices to the violators and appropriate action following the notices would be taken by the licensing authorities.
Apart from this, the DCA has also conducted raids on corporate hospital pharmacies to unearth expired medicines worth Rs. 65000.
Strengthening of DCA
Earlier the Drug control department was a neglected department. In 1976, when a separate department was created for DCA, there was only one director, two joint directors, two deputy directors, eight ADCs and 55 drug inspectors. This situation continued up to 2007. However since past few years now, things have changed.
As more and more pharmacies and drug manufacturing industries flourished in the state, the department had also gradually strengthened its roots throughout the state. Currently, all the 23 districts in the state have separate licensing authorities. Each district has an ADC with licensing powers.
With two more additional ADCs, one in Hyderabad and one in Rangareddy district, there are 25 licensing authorities in the state for medical shops alone.
Unlike earlier, the DCA has speeded up its licensing services. It issues license in just 48 hours. Four licensing authorities, including a director, are dealing with the manufacturing industries and one joint director has been posted to look into the cases of blood banks. The number of ADCs has been increased to 29, two additional posts of joint directors have been created for enforcement, the number of deputy directors was increased from two to eight, and 75 posts of drug inspectors have also been created for the convenience of the public.