August 02, 2011
In the wake of the NDM-1 controversy, the Government of India created a committee to frame a new antibiotic policy for the country. One of the recommendations of this committee was to regulate the sale of antibiotics by introducing Schedule H1 under the Drugs and Cosmetics rules, to regulate sale of antibiotics exclusively (Ministry of Health & Family Welfare 2011). The existing Schedule H contains 536 drugs, which cannot be legally dispensed without the prescription of a registered medical practitioner (RMP). The packaging of these drugs must include the warning Schedule H drug – warning: To be sold by retail on the prescription of a Registered Medical Practitioner only. Schedule H1 was envisioned as a tool to enable strict regulation of the sale of third generation antibiotics, despite the fact that regulation of the other Schedule H drugs is rarely enforced.
The antibiotic policy written by this committee is currently under review by the Union Law Ministry, after which it will be reviewed by the Drugs Technical Advisory Board (Assary 2011). The proposal (for what is now called Schedule HX) contains two parts. Part A consists of 16 antibiotics that should only be sold in tertiary hospitals. These drugs will be color-coded to enable quick identification. These 16 drugs include Cefpirome, Colistin, Doripenem, Ertapenem, Imipenem, Linezolid, Meropenem, and Moxifloxacin (Assary 2011).
Part B contains 74 drugs that could only be sold at pharmacies to patients with two copies of a prescription from a RMP. These include Amoxicillin, Ampicillin, Cefaclor, Cefalexin, Cefdinir, Ciprofloxacin, Erythromycin, Gentamicin, Norfloxacin, Oxacillin, Pencillin, antibiotic eye drops, some drugs for tuberculosis, sleeping pills, paracetamol and cough syrups such as Benadryl (Assary 2011; Deshpande 2011; Times News Network 2011).
Some Ministry of Health officials and doctors have defended the new regulations, pointing out that only very specialized, expensive drugs will be limited to tertiary hospitals, and that it is important to restrict these antibiotics to stem the spread of antibiotic resistance (Deshpande 2011; Express News Service 2011). Indeed, in situations where diagnostic and antibiotic sensitivity tests are unavailable, it is unwise for patients to take expensive, strong drugs. These drugs should only be prescribed when it has been determined that the patient is resistant to milder, widely available antibiotics through diagnostic tests. If patients are wantonly prescribed newer antibiotics, such as those restricted to tertiary hospitals, this will lead to a decrease in their effectiveness when patients with resistant infections really need them.
However, several parts of this new regulation have caused widespread protest. The All India Organization of Chemists and Druggists (AIOCD) has pointed out that in many rural areas, RMPs are scarce or unavailable, making many drugs inaccessible to rural populations (Deshpande 2011). Others fear that new regulations will make life-saving drugs scarce, and lead to increased use of the black market (Indian Pharmacist Association and Pharmabiz 2011). To show their opposition, several pharmacists organizations staged a strike on August 1st (Express News Service 2011; Indian Pharmacist Association and Pharmabiz 2011; Times News Network 2011). However, many re-opened during the day due to the protests of customers and police (Express News Service 2011). After a meeting with the Health Minister, the strike was officially called off in Delhi and other locations, based on the feeling that there is still time to change the specifics of the new regulations before they are enacted (Ahuja 2011; Indo-Asian News Service 2011).
These controversial new regulations raise a number of interesting issues. Of course, pharmacists are only part of the picture. The new antibiotic policy contains measures targeting overprescribing of antibiotics as well, such as educational programs for physicians (Ministry of Health & Family Welfare 2011). Preventing doctors from primary and secondary level facilities from dispensing the newest antibiotics without the diagnostic tests to determine whether they are necessary could also go a long way towards preserving the effectiveness of new antibiotics, which would ideally only be used when absolutely necessary. However, these regulations may have been diluted by the inclusion of drugs other than antibiotics. I find it hard to believe that I will actually be unable to buy paracetamol (acetaminophen) and cough syrup once these new regulations are put in place. Just in case, I m planning on stocking up.
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References:
Ahuja, S. (2011). Chemists to remain open on August 1. Hindustan Times. Gurgaon.
Assary, G. (2011). Losing battle against bacteria? Deccan Chronicle. Thiruvananthapuram.
Deshpande, D. (2011). Chemists super bugged by govt s new policy. Pune Mirror. Pune.
Express News Service (2011). Chemists strike over new rules for drug sale, leave patients stranded. Indian Express. New Delhi.
Express News Service (2011). Chemists to down shutters on Aug 1 to protest antibiotics order. Indian Express.
Indian Pharmacist Association and Pharmabiz. (2011). “AICDF calls for pharmacy bandh in Delhi & Haryana against govt s decision to include Schedule HX in D&C Rules.” Retrieved July 29, 2011.
Indo-Asian News Service (2011). Chemists end strike after meeting Ghulam Nabi Azad. NDTV. New Delhi.
Ministry of Health & Family Welfare. (2011). “National Policy for Containment of Antimicrobial Resistance – India.”
Times News Network (2011). Druggists warn of stir over move to ban 90 OTC drugs. Times of India. Hyderabad.
Image source: Flickr: streamingmeemee (Tim Carter)
