The Indian Pharmaceutical Association (IPA), the apex body of pharmacists in the country, is likely to oppose the Central Government's proposed move to amend Schedule K of the Drugs and Cosmetics Act to allow sale of household remedies through unlicensed outlets.
IPA's opposition has come as a surprise support to the drug traders, who are lonely opposing the move fearing loss of 15 per cent of their annual business to the tune of Rs.4000 to Rs.5000 crore.
"The move is detrimental to the interests of pharmacists and demeaning the profession of pharmacy. Many of the drugs under household remedies have to be dispensed carefully under the supervision of pharmacists. In a country like India, it is not desirable to allow sale of drugs through general shops", Subodh P Priolkar, president, IPA told Pharmabiz.
He said the association would soon forward its comments to the Government. The draft notification was issued in the middle of August with a 45 days time for comments from the public, by which the suggestions and complaints have to be filed by September end.
Meanwhile, the drug traders under the banner of All India Organization of Chemists and Druggists (AIOCD) have submitted a memorandum to the Union Health Minister and secretary, Department of Health & Family Welfare, Government of India, demanding withdrawal of the proposal.
The traders said the move could act as an incentive to clandestine spurious drug manufacturers and traders, and risk the lives of illiterate poor people in the country. Many of the drugs mentioned in the household remedies require medical supervision. For example, Iodochlor Hydroxyquenoline 250 mg, an anti diarrhoeal drug, cannot be prescribed to children less than 12 years of age. Prolonged and indiscriminate use of paracetamol could induce liver damage. Some of the steroids that come under Schedule K cannot be prescribed to pregnant women. Some of the anti-septic creams have a track record of causing Adverse Drug Reactions (ADR) and have to be used as per strict medical supervision. Similarly, inhalers have to be used under medical supervision. Further, it is discriminatory to the profession of pharmacists, as per Section 12 and 33 of the Drugs and Cosmetics Act.
AIOCD noted that the move itself is against the recommendations of the high level Mashelkar Committee, constituted by the previous Union Government, to suggest measures for weeding out spurious drugs from India. That committee consisted of senior regulatory officers and drug controllers of various states, experts, industry representatives, NGOs, consumer activists etc. The Committee had recommended bringing more drugs under the OTC ambit could 'act as an incentive to clandestine activities of spurious drugs'.
"The secondary market is particularly vulnerable and unscrupulous traders could be the target for selling spurious drugs'. Enormously large number of retail outlets does strain the economic viability of traders. State licensing authorities should step up regulatory activities, with support of police and other stakeholders. Good Pharmacy Practices (GPP) should be strictly implemented to weed out spurious drugs, the committee had recommended.
AIOCD noted that in developed world where large-scale sale of OTC drugs are allowed, the Governments have put in place adequate legislations to protect the health and safety of their consumers.
AIOCD sources noted that India has over 5.5 lakh retail drug outlets and medical stores are available in remote villages and even in places like Nathula Pass, the Indo-Chinese border above 30,000 feet from sea level. Allowing OTC drug sales in the name of non-availability of drugs in rural areas is an attempt to help the interests of drug manufacturing industry lobby, it alleged.