Sunday, 4 June 2017

Revisiting the Generic Drugs Controversy: The MCI Circular

Revisiting the Generic Drugs Controversy: The MCI Circular Dr KK Aggarwal National President IMA The 2016 amended clause 1.5 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 reads: "1.5 - Use of Generic names of drugs: Every physician SHOULD prescribe drugs with generic names legibly and preferably in capital letters and he/ she SHALL ensure that there is a rational prescription and use of drugs." MCI by a circular dated 21.04.2017 has reinstated that all the Registered Medical Practitioners under the IMC Act are to comply with the aforesaid provisions of the Regulations in its letter and spirit and has warned that any violation will attract disciplinary action by the concerned SMC/MCI. “Every physician” means all those who are registered with MCI or the State Medical Council. “Should” means discretional and not mandatory. “Prescribe drugs with generic names” means writing the chemical name of the drug. This is not synonymous with generic drugs. Remember there are two types of drugs: generic and patent drugs. If the clause meant patent drugs then doctors cannot write new-innovation drugs as they will be under patent for ten years. All new discoveries of ICMR, biotechnology department then will be out of the prescriptions. The purpose of writing generic name of the drug is to reduce prescription errors due to multiple brands of the same drug. Branded drugs are drugs sold under a trade mark within the validity of patent life by the innovator or their licensee. Generic drug is the nomenclature of a drug adopted post expiry of its patent. It does not include the word “only’. If that was written, one could not write the brand or the name of the company. Than we could not have written Jan Aushadhi drugs. It does not mean that one can write only the generic names. Also, it does not prohibit a doctor from writing the name of the company or the brand or Jan Aushadhi. “Legibly” means readable (does not mandate electronic prescription) “Preferably” means where ever possible (it is non-mandatory) “In capital letters” (pertains to the chemical name, again non-mandatory as some names may be complicated or with very long salt name) “And he/ she shall ensure that there is a rational prescription and use of drugs”, use of the word “shall” means that this part of the clause is mandatory. Only this mandatory portion of the clause, with the word ‘SHALL’ can be actionable. “that there is a rational prescription and use of drugs", the prescription shall have rationality of treatment and the drugs prescribed. As per WHO, rational use of medicines requires that “patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements, for an adequate period, and at the lowest cost to them and their community.

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