DCA seizes large quantities of physician's samples, duplicates of popular brands
In the ongoing raids to seize spurious drugs and detect other violations, the drug control officials found huge stocks of "Physicians Samples, Not for Sale" from different places in Hyderabad. In a surprise raid on the premises of one Krishnaiah at Dayara Market, Musheerabad, the Inspectors seized huge stocks of drugs marked as " Physician Sample, Not for Sale" worth more than Rs 1 lakh. In another seizure of physician samples from a medical and general stores at Kukatpally, 11 varieties of drugs were seized. The shop was found to be selling the drugs without a qualified pharmacist.
The officers seized under the Magic Remedies (Objectionable Advertisements) Act, 1954, 16 drugs manufactured by five different units at Lakshmi Homoeo Stores, Bhagyanagar Colony. Under the same Act three drugs for heart related complaints, diabetes and paralysis were seized from Life Saver Services. The company is found to have manufactured the drugs without holding any drug licence.
P Anantha Sayanam Reddy, Additional Controller-General, Drugs and Copyright, Drug Control Administration, told Pharmabiz.com that his officers had raided several manufacturing units, medical shops, including Homoeo and Ayurveda, throughout the state and seized spurious and substandard drugs, injections and magic remedies worth over Rs 2 crore during the last three months. The spurious drugs included Viagra tablets under the brand name of American multinational Pfizer, Betanicol Chloride tablets of Glenwood of Germany and Cifran tablets under the brand name of Ranbaxy Labs. Raids were also conducted at six manufacturing units indulged in the manufacture of drugs for which they were not granted any licence. The drugs include Sildenafil Citrate, approximately valued at Rs 50 lakh.
During the year, the department had cancelled the licences of 329 retail medical shops in the state for not complying with the regulations. Besides, 910 shops were issued show-cause notices and 521 licences were suspended. Among the manufacturing units, 44 licences were cancelled, 28 were issued show-cause notices and eight were suspended during the year.
There were about 200 fresh violations relating to spurious, misbranded, adulterated, not up to licensed quality as per the Pharmacopeial standards, under the Drug and Cosmetic Act, 1945, Magical Remedies Act, and Drug Price Control Order. There were also 25 convictions with jail term and fine this year. Reddy said the jail term ranged from one month to three years depending on the nature of violations. There were about 600 pending cases at different stages.
The DCA has set up a Task Force, under the Joint Director, to collect information, organize raids, monitor the cases and conduct follow-up action. Reddy said the department was working in a vaccum as no complaints were forthcoming from the doctors, general public and the medical shops regarding spurious drugs.
He said there were 32,000 registered medical shops and pharmacies, 1854 manufacturing units (200 bulk and 460 formulations), 154 blood banks, 185 cosmetic units, over 800 loan licences, 29 packing units and eight approved labs under the purview of DCA. The department had only 54 inspectors, even though there was need for one Inspector for every 100 shops and 25 manufacturing units as per the Hathi Committee report. Reddy said Dr Kodela Sivaprasad Rao, Health Minister, had sanctioned 50 more Inspectors and that would take care of the shortage of staff and effective implementation of drug control regulations.
As regards blood banks, Reddy said there were 76 violations and all were served with show cause notices. 'Stop production' notices were issued to three blood banks, one licence was cancelled and two charge sheets were filed this year. The violations pertained to non-availability of technical staff, lack of proper cold storage facility, not doing blood tests and not keeping records. Last year there were 99 violations.
The court cases consume a lot of time. With 600 pending cases there would be at least two or three cases coming up every day in the court and the concerned Inspector would have to be present. If the inspector were not present, the case would be rejected. This puts tremendous pressure on the already under-staffed department.
Another problem being faced by the department is lack of coordination with other states. Most of the spurious drugs are coming from other states and it was very difficult to track down the culprits without the active support of the officials and police there.