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With indiscriminate inspections and raids by the officials of the excise enforcement and anti-narcotics special squad at the medical stores day by day in Kerala, the All Kerala Chemists and Druggists Association (AKCDA) has decided to cease the procurement and sale of Schedule H1 category of drugs.
The sale of as many as 46 drugs come under this category will be resumed only after the state government declares a halt on ‘excise raid,’ said A N Mohan, senior vice-president of AIOCD and state president of the AKCDA.
He alleged that the excise officials conducted inspections and raids at the pharmacies without giving prior information to the drugs control department. The raid at the chemist shops by officials out of drugs control administration will tarnish the image of the pharmacies and a feeling of distrust will be generated among the masses about the drugs sold from the shops.
When Pharmabiz contacted B Hariprasad, the state drugs controller, he said the decision of AKCDA is unfortunate and it is a violation of the provision of DPCO. He said government of India had brought 46 drugs and their formulations under this restricted category in 2013 by considering drug resistance as a serious health hazard. The Schedule H1 was introduced to control misuse of third and fourth generation antibiotics, anti-TB and some habit forming drugs.
To a question he said the major habit forming drugs include tramadol, codeine, diazepam, nitrazepam, and alprazolam. Alprazolam is an anti-anxiety drug that induces sleep. Tramadol, codeine, diazepam and nitrazepam are used for treating severe pain, anxiety and insomnia.
The drugs controller further said the state health secretary held discussion with the excise commissioner in the issue, and in future the raiding excise staffs will take along the concerned drug inspectors and will not initiate any punitive action against the medical shops.
According to the state regulator, the excise department has strengthened inspections including drug stores because of increasing illegal sale of ganja products and intoxicating materials. He revealed that as there is rampant self-medication and misuse of antibiotics in Kerala, the raid would help reduce it to a larger extent.
As per the Drugs and Cosmetics Act, the Schedule H1 preparations should be taken in accordance with the medical advice, and it cannot be sold by retail without the prescription of a registered medical practitioner. Further, details of the sale of this category drugs, including the names and addresses of the prescriber and the patient, has to be documented by the pharmacist at the medical store and it should be maintained for three years and be open for inspection.
The All India Organization of Chemists and Druggists (AIOCD) had objected to notification of the list of drugs in Schedule H1 in March, 2014 citing several reasons. But the government implemented it. Now the decision of AKCDA, an affiliate of AIOCD, is to create a deadlock in the circulation of medicines forcing the government to intervene and stop the inspections by excise staff, an officer from the DC department opined.
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