without ensuring quality, it is not good for the DGHS to force doctors to prescribe generic drugs

without ensuring quality, it is not good for the DGHS to force doctors to prescribe generic drugs

The Director General of Health Services (DGHS)

• issued yet another order on May 12 giveing directions that doctors in Central government hospitals prescribe only generic medicines instead of branded drugs.

• Reason   that doctors are in cahoots work / acting together with others for an illegal  with the pharmaceutical industry wherein the doctor receives a kickback रिश्‍वत for each prescription of a particular company’s drug.

Gov forcing them to write only the generic names  

of medicines, the hope is that the pharmacist will provide the patient with the cheapest available generic drug and thus save them the cost of the more expensive branded drugs. 

This policy objective  pharmacist is a benevolent individual who does not have his own incentives to sell the patient more expensive branded drugs. 

Quality of generic medicines

Directorate should conduct a survey  

But before threatening its doctors, perhaps the Directorate should conduct a survey among government doctors asking them to explain their reluctance to write prescriptions with just the generic names. 

 doctor do not trust the quality of all generic medicines 

1 It is no secret that many Indian doctors in both the public and private sector simply do not trust the quality of all generic medicines in the Indian market. 

2 They have a valid reason for this: 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.

अमेरिका के नियम कानून

The U.S. created this environment

of trust by mandating as far back as in 1977 that most, but not all, generic drugs be tested on human volunteers in order to measure the rate at which the drug is bioavailable;

 i.e. the rate at which the drug dissolves in the bloodstream. 

Such testing is required because generic manufacturers may use different materials like binders, coating and punching machines which directly affect the ability of the drug to dissolve in the blood.

 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.

🍎🍎🍎🍎🍎🍎🍎🍎🍎🍎🍎

What Is Bioequivalence?

Bioequivalence is the biochemical similarity of two (or more) drugs that share the same active ingredient(s) and desired outcome(s) for patients. Pharmacokinetic studies must be done to determine whether a commercially available brand and a potential generic version share core attributes. 

Bioequivalence or pharmaceutical equivalence must be present showing that the two drugs release the active ingredient into the bloodstream at the same amount, the same rate, and have the same quality.

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भारत के कानून

India mandated such bio-equivalence testing only in 2017. 

 a recommendation by the Drugs Technical Advisory Board (DTAB) to ensure that existing generic drugs, approved prior to 2017, also be tested for bio-equivalence, was ignored by the government.

 This means that 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.

If the government cannot provide such a legal guarantee, it should not be barring doctors against prescribing their preferred brands. 

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.

Stability testing

The lack of bio-equivalence testing is just one of the issues with generic medicines in India. 

The other massive problem is the issue of stability testing

1 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. 

2 An unstable drug will start decomposing, possibly reducing its efficacy. 

3 Sometimes a tablet will just crumble into powder when removed from its packaging.

 In other instances, the tablet will be visibly discoloured or if it is a liquid, particulate matter may be visible.

 Many of these problems can be checked if the law prescribed mandatory stability testing prior to providing marketing approval and also while the drug is in the market. 

What we did in past 

This common requirement across the world became mandatory in India only in 2018, after the government managed to overcome immense opposition from the pharmaceutical industry.

 But once again, the new regulations not only lacked scientific rigour सख्ती   but also did not apply retrospectively to generic drugs approved prior to 2018. This means that many generic medicines in the Indian market have not been subjected to mandatory stability testing. This could be an additional reason contributing to quality issues that undermines the trust of governmnent doctors in generic drugs.

Given these issues related to the quality of generic drugs, it is not appropriate for the DGHS to force doctors to prescribe drugs by generic names. Rather, the DGHS must work towards resolving the genuine concerns being raised by doctors. A starting point would be 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.

source the Hindu