Saturday, 23 September 2006

OTC drugs may open Pandora's Box

2006
By Syed Akbar
Hyderabad, Sept 23: The Central government's decision to allow sale of certain medicines through ordinary grocery stores is likely to open the Pandora's Box.
Health and medical experts are divided over the feasibility of the government's move as a majority of people in the country are illiterate and there's every possibility of the over the counter drugs being misused. Doctors fear that even seemingly harmless medicine like iron tablets will cause severe health complications if it is not stored properly. While those in favour of the government's move argue that over the counter sales would help the poor as they generally do not have access to a general physician.
The Central government has given time till September 26 for people to send in their suggestions and objections on the draft notification for sale of drugs in grocery stores. After September 26, the government will issue a notification after which it becomes law.
"Most of the medical stores in the country do not have proper storage facilities. We can least expect facilities in ordinary grocery stores. In medical shops at least shopkeepers have the knowledge of pharmacy. Unless the government ensures that shopkeepers are properly trained in pharmacy, the over the counter sale of medicines will prove to be harmful than beneficial," argues Dr Bhaktiyar Chowdhury of Hyderabad Spine Clinic.
Even the Indian Drug Manufacturers' Association has objected to the government's decision saying that only a few medicines should be sold through grocery stores. It argued that India did not have sufficient number of qualified pharmacists and infrastructure to preserve the drugs well.
At present only grocery stores in villages with less than 1000 population are permitted to sell select medicines. Once the Act comes through, grocery stores all over the country will be able to sell medicines which do not require prescription of a qualified registered medical practitioner.
According to industry sources, despite strict restrictions medicines worth over Rs 5000 crore are sold through over the counter process every year. The segment has been recording an annual growth rate of 12 to 15 per cent and this is precisely the reason why multinational companies are bringing pressure on the Centre to amend Schedule K of Indian Drugs and Pharmaceutical Act to permit sale of medicines through grocery stores.
"Bad storage facilities, wrong prescription and failure to comply with the expiry date can be extremely harmful to patients. The problem does not relate to just serious side effects including death but also to meeting specified bioavailability and bioequivalence criteria of drugs," points out Dr B Murali of Care Hospital.
Ironically, some of the drugs which the government wants to permit through OTC sales are known to cause side effects or have drug interactions and disease interactions. Permission for sale of non-steroidal anti-inflammatory drugs, gastrointestinal medicines and prochlorperazine will be dangerous to the health of people.
Senior physician Dr S Ramachandra Rao suggests that drastic changes in the labelling practices of over the counter medicines should have to be strictly enforced. OTC drugs should be labelled in local regional and local languages with clear instructions to patients. "It has to be ensured that all OTC drugs specify the correct prescription particularly in case of children like quantity, frequency and duration of the intake," he said.
Non-steroidal anti-inflammatory drugs like ibuprofen, mefenamic acid, ketoprofen and dictlofenac, gastrointestinal drugs like domperidone and loperamide and prochlopreazine may damage kidneys in case of overdose, warns Dr Murali.
Health experts also warn over sale of potentially dangerous drugs like iodochlorohydroxy quinoline, which is banned in many countries but sold in India. This drug is likely to cause blindness. Even anti-malarial drugs and ophthalmic solutions have been proposed for sale through grocery stores.

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