28 December 2011
By Joseph Alexander
New Delhi India
With a view to promote rational use of medicines, the health ministry is planning to introduce a system to make compulsory the use of generic names or the international non–proprietary name (INN) at all stages of production and distribution.
Apart from this, the ministry also will take up with other concerned departments including the Department of Pharmaceuticals (DoP) the issue of making the code of conduct mandatory, instead of just having a voluntary code for the pharmaceutical companies.
These are among a number of measures being planned by the ministry based on the suggestions by an expert panel to be implemented during the next five year plan period, sources said. Use of generic names or INN should be encouraged at all stages of procurement, distribution, prescription and use as it contributes to a sound system of procurement and distribution, drug information and rational use at every level of the healthcare system, according to the expert panel.
“Pharmaceutical marketing and aggressive promotion also contributes to irrational use. There is a need for a mandatory code for identifying and penalizing unethical promotion on the part of pharma companies. The Ministry of Health and Family Welfare will set up a Committee to review and suggest measures for the effective implementation of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (DMRA). The Health Ministry in collaboration with MCI should incorporate into the medical, pharmacy and nursing syllabus rational use antibiotic policies, and promotion of generic medicines,” the panel said.
“A comprehensive law is required to mandate prescription audits, a measure necessary to curb drug resistance. The DCGI and FSSAI will jointly examine the nutraceuticals having multivitamins, minerals etc. for prophylactic and therapeutic purpose,” the report said.
Irrational FDCs, non–essential vitamins/tonics, cough syrups feature in the top selling pharmaceuticals in terms of value and volume but they harm public health and patients by increasing adverse effects, imposing higher financial burden on patients and facilitating – emergence of drug resistance (in the case of FDCs of antibiotics). Therefore, stricter criteria for registration and – regulatory review of medicines by CDCSO should be a priority. This helps to weed out substandard, toxic, irrational medicines from the market, the panel said.
“CDSCO implements a much stricter registration regime for FDCs. Products should be selected and approved only when the combination has a proven advantage in therapeutic effect, safety, adherence or in decreasing the emergence of drug resistance in malaria, tuberculosis and HIV/AIDS. Except FDCs included in the WHO’s essential Drug List, all FDCs registered in India are reviewed in terms of their therapeutic effect and legally sustainable action taken for phased out weeding of all irrational FDCs, DTAB should set up a suitable mechanism for the purpose,” the panel said.