Launching of a website giving information on banned drugs and other relevant details, the implementation of the use of aprons and gloves by the shopkeepers and the presence of a pharmacist in all pharmacies are some of the priorities for M Venkat Reddy, the new Director of the Drug Control Administration in Andhra Pradesh.
The Drug Control Administration (DCA) in the state is very active and because of its concerted drive against spurious drugs and drugs not of standard quality (NSQ), it was able to ensure conviction of 20 people last year and detected 9 spurious drugs from January 2003.
Venkat Reddy was till now Joint Director in charge of the Task Force responsible for conducting raids and detecting a large number of spurious drugs and finding hundreds of violations under the overall guidance of C P Ananthasayanam Reddy, Additional Director-General for Drugs and Copyright, an IPS officer.
Talking to Chronicle Pharmabiz, Venkat Reddy said DCA would be launching a website of its own in August giving information on banned drugs, drugs which are not of standard quality, licensed medical shops and other details on the state drug sector.
He said though DCA was understaffed, it effected a large number of raids and seized spurious drugs worth several lakhs of rupees. The department was working with 50 Inspectors as against a requirement of about 250 officers as per the Hathi Committee report. However, the shortage of staff did not affect its working, he said.
DCA has 8 Asst Directors, two Dy Directors, a Joint Director and a Director. The office is headed by the Additional Director-General for Drugs and Copyright. DCA has two labs, one at Hyderabad and the other at Vijayawada, headed by the Joint Director. It has three government Analysts, two at Hyderabad and one at Vijayawada, and 28 technical staff to analyse the seized samples.
It is a mammoth job for the department as AP has 22,600 retail licensees and 8,515 wholesale licensees. There are 1513 drug manufacturing units, including 197 bulk drug units, 404 formulations units, 5 large volume patent drug units, 14 vaccines and sera units, 57 cosmetic units, 603 loan licensees, 178 blood banks, 26 repacking units and 8 approved laboratories as on June 1, 2003.
Venkat Reddy said in 2000-01, the officers picked up 3,588 samples for testing and 179 samples were declared as 'not of standard quality.' In 2001-02, 3566 samples were analysed and 151 were found not of standard quality. In 2002-03, it analysed 3976 samples and 147 were found not of standard quality. So far DCA was able to achieve 800 prosecutions in different courts with 85 % conviction rate. In two cases, the accused were convicted for more than 10 years in jail. In several other cases, the accused were convicted for 6 months to three years jail term. In some cases the licences were either cancelled or suspended, he said.
Most of the counterfeit drugs were entering the state from Tamil Nadu, Delhi and Uttar Pradesh. Usually it is a case of unscrupulous elements trying to cash in on the popular, fast-moving drugs by replicating them. Fake Rhoclone vial, antibiotics like Cifran-500 of Ranbaxy, pain killer Nise, Crocin, and Analgin are the most common cases. Viagra, purported to be manufactured by Pfizer, and Beta-Nicol Chloride tablets, purported to be manufactured by Glenwood GmbH, Stanburg, Germany, have also been seized. The duplicates are so close to the original that it is difficult to find out the fake from the real.
Ayurvedic drugs containing Sildenafil Citrate for male potency, Ayurveda pills containing Beta Methasone and Crticosteroid for asthma are among the several drugs seized. Stocks of hospital drugs 'not for sale' and meant for the governments of Orissa, AP, Kerala, Tamil Nadu, and the CGHS were also seized from doctors, stockists and institutions.
The officials conducted surprise raids on 507 medical shops with special emphasis on detecting sale of habit-forming drugs without prescription and issued notices to all the shops. More than 100 drugs under the Magic Remedies were detected and complaints were filed against the manufacturers and the dealers. DCA also organised raids on 70 blood banks during Feb./March this year and show-cause notices were served on four blood banks.
Asked about the problems being faced by the department, Venkat Reddy said they were not getting any complaints from the general public, doctors and the hospitals regarding spurious drugs and other violations. The courts take several months, and even years, to hear the cases and give the verdict. This was time-consuming for the already under-staffed department because the officers had to appear before the court for the hearing every time. The department has, therefore, asked for special courts or designated courts in every district or the inspection area to deal with these violations. Communication facilities like government vehicles and cell phones would help provide fast and prompt execution of raids on suspected shops/dealers/manufacturing units.
Asked about his future plans after taking over charge as Director, Venkat Reddy said he would insist that medical shops must be kept hygienic and the staff must wear white aprons and gloves while dispensing drugs, keep a thermometer and record the temperature of the shop at least three times a day, air-condition the shop with an alternative of air-cooler with exhaust fans, keep photo-sensitive drugs in cool and dark place or in a blue-paint almirah, keep expired drugs in a separate track meant exclusively for the inspection purpose and maintain a record of that. Fresh licences will be issued only to qualified pharmacists or to a partnership. The pharmacist must be present in the shop during the dispensing hours.
He wants the shops to make all purchases from bona fide traders and manufacturers and payment must be preferably by cheque or DD. He will insist on the manufacturers to supply the price list and the drug formula to DCA. If there are any DPCO (Drug Price Control Order) violations or inferior quality drugs, action will be taken against the guilty.