Spare the rod and change the law

Context: 

The Director General of Health Services (DGHS) ordered reiterating directions that doctors in Central government hospitals prescribe only generic medicines instead of branded drugs.

Objective of the order:

• The driving force behind these office orders is the hope to provide the patient with the cheapest available generic drug and thus save them the cost of the more expensive branded drugs. 

Why is there reluctance with generic names?

• Many Indian doctors in both the public and private sector do not trust the quality of all generic medicines in the Indian market. 
• India has lagged behind countries like the U.S. in creating the appropriate legal and scientific standards that provide guarantees to doctors on the interchangeability of generic medicines with each other and the innovator drug.
• Many doctors have developed faith in particular brands, not because they receive bribes but because patient feedback has taught them that other brands do not work as effectively.

“Bio-equivalent” position in India:

• If the dissolution profile of the generic drug is same or similar to that of the innovator drug over a time period, it is declared to be “bio-equivalent” and hence therapeutically interchangeable with the innovator drug.
• India mandated such bio-equivalence testing only in 2017. Even then, the regulations were vague. A vast majority of drugs in the Indian market have never been tested for bio-equivalence. 
  • Hence, the government cannot provide doctors with a legal guarantee that all generic medicines in the Indian market are, in fact, interchangeable with the innovator drug.

Issues with generic medicines in India:

• The lack of bio-equivalence testing.
• The issue of stability testing 
  • The key challenge to manufacturing any drug is to ensure that it remains stable through a stressed supply chain in differing conditions of heat and humidity.
• Many generic medicines in the Indian market have not been subjected to mandatory stability testing which undermines the trust of government doctors in generic drugs.

Time to focus & action:

• The DGHS must work towards resolving the genuine concerns being raised by doctors.
• To ask for regulations which require pharma companies to identify on their packaging whether a drug has been tested for bio-equivalence 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 for failing to comply with directives on mandatory prescription of drugs by their generic names.

News Source: The Hindu

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