The Andhra Pradesh drug control administration (APDCA) and Telangana drug control administration (TSDCA) both have increased the drug regulatory activities to ensure strict implementation of drugs and cosmetic and copy right act in both the states.
Post bifurcation , both the state have been working to strengthen the drug regulatory systems in and have increased activities to ensure safety and standard quality of drugs available to common man .
However there are also problems that are hampering the delivery of full-fledged services. Basically both the states are suffering from staff crunch and lack of regular training to the employees.
Particularly the newly carved out state of Telananga needs more sample testing centres. Except for Hyderabad, there are no major sample testing centres in the districts. Since past one year after bifurcation, the employees division had become a problem, but now slowly all the problems are slowly being resolved.
Bifurcation process completed
According to Drug Control Administration sources, the bifurcation process of drug control administration for two states is completed. Employees at the head quarters have been divided based on their nativity and place of appointment. “Provisional allocations of employees have been completed at the head offices in the capital city. As Hyderabad is a common capital for 10 years, the same drug controller campus is shared by both the states. The files and documents of companies have been separated with respect to the state of their location. Though a lot of work is still pending, it will be completed within next couple of months,” said a senior officer at DCA.
The offices of Director General for Drug Controller for Telangana and Andhra states are at present located in the same campus. “In fact there is not much to be divided at the headquarters except files and employees. Already there are drug control offices in each district both in Telangana and Andhra regions, so employees and drug inspectors in their respective districts will be retained as usual. Our major focus is to do service to the pharma and drug manufacturing firms in both regions. We are issuing product license as usual and at the same time enforcing the Drugs & Cosmetics Act as usual, but from two different offices” said the officer.
The present Andhra Pradesh drug control administration is headed by Director General Dr. Ravi Shankar an IPS officer. Under his direction, the APDCA is implementing the Drugs and cosmetic and copy right act in the state.
The Telangana state DCA (TSDCA) office is headed by Akun Sabharwal, Director General of TSDCA and senior drug controller Amruth Rao appointed from Telangana region. The Andhra DCA will work under the AP health ministry headed by Kamineni Srinivas Rao, while the Telangana DCA will work under the Telangana state health minister Dr. Laxma Reddy.
With the formation of two drug control administrations for both the states, now their focus is to ensure that the quality drugs are made available at affordable prices to the people. Pharmacies, blood banks and drug manufacturing companies are also divided accordingly and the respective DCAs will issue licences and enforce the Act.
In addition to checking of efficacy, quality, purity and strength and good manufacturing practices and good storage conditions, the Drugs Control Administration offices in both Telangana and Andhra is also entitled to regulate the manufacture, sale and distribution of drugs to ensure their quality and efficacy. The TSDCA and APDCA will have to basically focus on implementing Central legislations which include the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945, Drugs (Prices Control) Order 1995, the Drugs and & Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules made there under, the respective states Narcotic Drugs and Psychotropic Substances Rules, 1986, (Licensing part), Cigarettes and other Tobacco products.
Activities of TSDCA
Enhancing its activities to ensure safe and quality drugs, TSDCA recently conducted test conducted on drugs samples collected from various sources across the state. The authorities at TSDCA have found 21 medicines sold in Telangana to be of not-of-standard quality. Out of a total of 560 drug samples collected from different parts of the state, 21 were found to be not of quality standards. The TSDCA officials have blacklisted these drugs and are planning to further investigate the matter for taking action against the perpetrators as per the Drugs and Cosmetics Act.
“Out of 560 drug samples collected from the market, the lab tests by DCA officials have found that more than 20 drug samples were found to be not of standard quality. All these drugs are regarded as important and widely sold in the market,” revealed a DCA source.
“After laboratory tests revealed that 21 medicines were not of standard, DCA office has issued a warning to the public to avoid buying these 21 medicines from the market,” informed a senior official.
As per reports, some of the important drugs which were tested as not of standard quality include dexamethasone tablets, Cefixime, Mezo capsule, aspirin and paracetamol of companies like Nikem Drugs Private Ltd and Minopharm Labs. These drugs are widely prescribed by doctors across the state.
The guidelines for taking action on samples of drugs declared spurious or not of standard quality in the light of enhanced penalties under the Drugs and Cosmetics (Amendment) Act, 2008, passed by the Parliament on December 5, 2008 provides deterrent penalties for offences relating to manufacture of spurious or adulterated drugs which have serious implications on public health. It will help regulatory authorities to handle anti social elements involved in the manufacture of such drugs and playing with human safety.
The penalty for manufacture of spurious or adulterated drugs has been enhanced to an imprisonment for a term which shall not be less than 10 years but which may extend to imprisonment for life and shall also be liable to fine which shall not be less than ten lakh rupees or three times value of the drug confiscated, whichever is more.
In certain cases offences have been made cognizable and non-bailable. It also provides a tool of compounding of offences for dealing with certain minor offences. Under the Drugs and Cosmetics Act, 1940 control over manufacture and sale of drugs is exercised by the State Licensing Authorities. Licences for drug manufacturing establishments and sale premises are granted by the said authorities. Inspections/raids are carried out by the drug inspectors appointed by the states to ensure compliance of the conditions of licences.
Samples are drawn by drug inspectors to check the quality of drugs marketed in the country. Legal/administrative actions as required under the said Act and Rules for the violation of the provisions of the Act are taken by the State Licensing Authorities. The actions are normally initiated on the basis of test reports of government analysts declaring the drug samples as not of standard quality.
APDCA initiatives
Similarly the APDCA has also initiated various activates to strengthen the Drugs and Cosmetics Act in the remnant Andhra State. Particularly the APDCAs activities include enhancing the administrative aspects such as speedy issuance of licenses to the pharmacists through online system. Post bifurcation, the APDCA has focused on transparency speedy clearance to new drugs manufacturing licenses and product expansions. It is also focusing on regular inspecting pharmacies and hospitals for the better implementation of the Drugs and Cosmetic Act. Post bifurcation the APDCA has focused its activities towards Vijayawada, Guntur, Vishakhapatnam and other Rayalaseema districts in Andhra Pradesh.