In a bid to meet the ever-growing challenges, the Andhra Pradesh Drug Control Administration (APDCA), having the mandate to inspect, check and verify the quality and safety of medicines in the state, is continuously streamlining its administrative functions by adopting new age information and communication technologies.
In order to weed out unscrupulous drug manufacturers, check unregistered pharma stores and to contain spread of spurious drugs in the state and to provide rapid, professional, transparent and effective client services, the Andhra Pradesh drugs control administration under the dynamic leadership of Dr. B.L Meena, Director General, APDCA, has been taking various initiatives during the past few months since his taking charge of the office. The most significant among all the initiatives is the launch a new website.
“We are in the process of streamlining the entire administrative set up in the state, as a part of this initiative we have launched the new website through which we are aiming to provide fast, transparent, accountable and corrupt free administration,” said Dr. Meena.
Right from the inception in the year 1952, the drugs control administration has been instrumental in ensuring manufacture of standard quality medicines by conducting regular inspections of manufacturing sites, distributors and drug stores. With just four Drug Inspectors in the year 1952, today, the drug control regulator in the state has grown its strength to more than 125.
In the early days, the drugs control administration was functioning in the Directorate of Medical services campus. The main mandate was to ensure the implementation of the Drugs and Cosmetics Act, 1940 and Rules made there under (formerly called as The Drugs Act, 1940 and The Drugs Rules 1945) that was implemented only in the erstwhile Andhra state.
After the formation of separate Andhra Pradesh state in the year 1956, the DCA increased its capacity from four to eight Drug Inspectors and the implementation of Drugs and Cosmetics Act, 1940 also extended to the Telangana region of erstwhile Hyderabad state.
Subsequently, Drugs Control Administration was also entrusted with the enforcement of Prevention of Food Adulteration Act and the Head of the Department was designated as Drugs Controller and Food Health Authority. In the year 1981 the Department of Drugs Control Administration was accorded independent status with a separate Directorate headed by a Director functioning under the Ministry of Medical and Health, Government of Andhra Pradesh.
“The main objective of DCA is to ensure that the quality drugs are made available at affordable prices to the people. The drugs are used by the public for prevention, mitigation or treatment of diseases or disorders. The efficacy of these drugs depends on their quality, purity and strength and it in turn depends on their good manufacturing practices and good storage conditions. DCA regulates the manufacture, sale and distribution of drugs to ensure their quality and efficacy,” says the DG.
As a part of its mandate to protect lives of people by ensuring quality and safety of medicines, the drug regulator is authorized to implement various state and central legislations throughout the state.
Important central legislations implemented in the state are: The Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules1945, Drugs (Prices Control) Order 1995, The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules made there under, The Andhra Pradesh Narcotic Drugs and Psychotropic Substances Rules1986, (Licensing part) Cigarettes and other Tobacco products.
The organizational setup of various functionaries in DCA is broadly classified into enforcement and laboratory wings. While the enforcement wing enforces the provisions of above said enactments in the state and laboratory wing performs the test/analysis of various drugs and cosmetics samples sent for analysis and issues the certificate of test/analysis.
Achievements of APDCA
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, shops in the Govt. hospitals, Jeevandhara generic oulets, medical shops in any particular vicinity, banned drugs, not of standard quality drugs, prices of notified drugs and 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 authorised to grant and renew sales drug licenses, manufacturing licenses, approval for setting up of new testing laboratories, issue of WHO GMP certificates, fresh sale certificate, market standing certificate, production capacity certificate etc. 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 in DCA of earlier DG, R.P Thakur, the government of Andhra Pradesh had appointed Dr. Meena, as the new Director General of Drugs & Copyrights, Drugs Control Administration in the state. Dr Meena is a dynamic personality, dedicated and focused on achieving goals and accordingly sets targets to achieve them in time.
Within a short span of just six months time Dr. Meena, 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 1500 pharmaceutical companies, including bulk drugs and formulation majors and about 50,600 plus 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 in other segments over the past few years. Though more and more pharma companies are keen on setting up their base here, there are a host of problems that needs to be expeditiously sorted out. Hence the most important priority for the new DG is to further strengthen the drugs control administration in the state.
A major cause of concern 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.
As a part of its special drive to check the functioning of registered pharmacists in the state, the DCA has 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 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 schedule drugs without prescriptions at the stores.
Corporate pharmacies like Apollo, Hetero Pharmacy, Medimart and Medplus were also raided and booked as many as 1281cases against the medical shops.
As a part of its latest achievements, the state DCA has seized drugs worth Rs.1.5 crore since the new Director General Dr Meena took charge. The authorities have also filed nearly about 35 cases in the court against the manufacturers and distributors of spurious and unlicensed drugs in the state.
Among drugs seized under various types of violations, the spurious drugs alone accounted to Rs.70 lakhs.
Apart from conducting regular inspections of manufacturing sites, the DCA is also conducting regular inspection drives of blood banks, drug stores and retail medical shops in the state.
“Our goal is to have an accountable and transparent administration giving no scope for any kind of corruption. We are constantly interacting with all stake holders and planning to expedite licensing and other client services as per the time frame. To ensure quality and accountability we are conducting quarterly review meetings at the state level periodical meetings at head quarters and accordingly taking necessary action,” says Dr Meena.
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. Ultimately the APDCA is aiming to see that there is no scope for the fraudulent manufacturers and distributors of spurious drugs/substandard drugs in the state and at the same time ensure genuine law abiding manufacturers/dealers are not harassed.
Embarking on digital mode
As a part of its initiative to upgrade itself with the modern technology, the drugs control administration has recently launched its much awaited new website. The website was launched by Ajay Sawhney, I.A.S, Principal Secretary of Health Medical and Family Welfare department, Government of Andhra Pradesh. With this new website, the DCA has taken its administrative services to the next level of growth.
Speaking at the launch, Ajay Sawhney, said, “Though the drug control department is a small part of the big healthcare sector, its role is significant as it ensures safe and quality medicines reach the consumers. The launch of the website is the beginning for the drug control administration using which it can not only speed up its work but also provide effective services.”
With the launch of website, the DCA has immediately started issuing drug sales licenses, WHO GMP certificates and other client services at a faster, easier and in a time frame manner. This new website will also enable transparency and accountability on the part of DCA officials as it has been developed to monitor and check the movement of files on day to day basis.
The new website has a decent look with an innovative live logo and it has been designed comprehensively with fool proof security system. Some of the basic features of the website have been sourced from NIC Gujarat, and it has been augmented with some more advanced additional features overcoming the bottlenecks and security hurdles.