Health minister may not favour inclusion of Schedule HX in D&C Act

Mumbai, 5 Oct: The Drug Controller General of India (DCGI)'s proposal to introduce Schedule HX in the Drugs and Cosmetics Act (D&C Act) to regulate the use of antibiotics in the country may not be a reality in the immediate future as the union health minister is reviewing the proposal, it is learnt. According to sources, union health minster Ghulam Nabi Azad is not in favour of the implementation of the DCGI's proposal at its present form as there are fears that the implementation of the Schedule HX will not be practical in the Indian context as a large number of people are living in the remote areas of the country where there is a dearth of qualified doctors. The minister is learnt to have expressed the apprehension that if Schedule HX is introduced in the country at its present form, there is a fear that in the absence of qualified doctors, the patients may be in danger, and there is threat to their lives due to the unavailability of antibiotics. As per the DCGI's proposal, a new Schedule HX will be added to the D&C Act to make it compulsory to carry duplicate prescriptions. Both the doctors and chemists have to retain prescriptions so that the abuse of antibiotics could be checked. About 70 drugs including antibiotics will come under the new Schedule HX. Violations will be punished with a fine of Rs. 20,000 or upto 2 years imprisonment. The whole purpose of the move is to check the abuse of antibiotics. Currently, the antibiotics are included in the Schedule H of the D&C Act. In India, scientific debate on antibiotic resistance started in the wake of a recent controversy over a reference made in the medical journal, Lancet, regarding the superbug called New Delhi metallo-beta-lactamase 1 (NDM-1). The superbug is stated to be resistant to the most powerful antibiotics and the circulation of the Lancet report did hit the image of India as a destination for medical tourism. And it is in this background that the DCGI had set up a task force to review the current situation regarding manufacture, use and misuse of antibiotics in the country. Sources also said that the minister was also influenced by the apprehensions aired by the chemists and druggists in the country. The chemists and druggists have been objecting to the proposal on the plea that it will lead to acute shortage and non-availability of vital life saving drugs. They argued that as 70 per cent of the total Indian population is living in rural and remote areas where basic health services are not available, by introducing Schedule HX, the government is depriving the poor people of access to life-saving drugs. The minister wants a balanced and locally feasible solution to the issue as he has said that although resistance is a global problem, shared by developing and developed countries, India's solutions must be local and sensitive to constraints of respective health systems.

Pharmabiz