Source– The post is based on the article “ Spare the rod and change the law” published in The Hindu on 5th june 2023.
Syllabus: GS2- issues related to development and management of health
Relevance: Issues related to generic medicine
News- The Director General of Health Services (DGHS) issued directions that doctors in Central government hospitals to prescribe only generic medicines instead of branded drugs.
Why do Indian doctors lack trust in the quality of generic medicines?
Firstly, India has lagged behind countries like the U.S. in creating the appropriate legal and scientific standards ensuring bio-equivalence testing. It provide guarantees to doctors on the interchangeability of generic medicines with each other and the innovator drug.
India mandated bio-equivalence testing only in 2017. Drugs Technical Advisory Board (DTAB) recommended that existing generic drugs, approved prior to 2017 be tested for bioequivalence. But, it was ignored by the government.
Many doctors have developed faith in particular brands. The patient feedback has taught them that other brands do not work as effectively.
Second, it should be ensured that the drug remains stable through a stressed supply chain in differing conditions of heat and humidity.
The law prescribing mandatory stability testing prior to providing marketing approval became mandatory in India only in 2018. But it did not apply retrospectively to generic drugs approved prior to 2018.
What is the way forward?
Hence it is not appropriate for the DGHS to force doctors to prescribe drugs by generic names. The DGHS must work towards resolving the genuine concerns of doctors.
There is a need for regulations which require pharma companies to identify on their packaging whether a drug has been tested for bioequivalence and stability as required by the law.
Building the confidence of doctors in generic medicine serves public interest better than threatening them with punitive action.