Noida: The National Medical Commission (NMC) released, and then withdrew, guidelines for doctors, which included a clause asking doctors to prescribe drugs using generic names and to avoid irrational drug combinations. Several doctors and the Indian Medical Association (IMA) were against the mandatory generic medicine prescription, calling it ill-advised and citing poor quality of generic medicines and poor adherence to safety standards by generic drug manufacturers.

Yet others contend that the move could have helped improve access to drugs and that drug safety standards in India should not get in the way of access to medication. Brand-named medicines do not assure quality, KM Gopakumar, legal researcher on law and policy related to access to medicine and legal advisor at the Third World Network, an international non-profit research and advocacy organisation involved in issues relating to economic development, told IndiaSpend in an interview.

“Generic medicine'' is a term that is used interchangeably for drugs that are manufactured by companies other than the one who holds the patent for it (off-patented) or, drugs that are marketed under an international nonproprietary name without a brand name. Off-patent medicines, marketed by international pharmaceutical companies, and many domestic companies in India, are often produced by Indian contract manufacturers, and just the name of a brand does not guarantee that they would be safer or less likely to be contaminated, Gopakumar says.

Instead, he said, India should improve its pharmacovigilance system, while ensuring that patients can afford quality drugs no matter who is the manufacturer.

IndiaSpend spoke to Gopakumar about the NMC guidelines, how they would affect the public healthcare system and the medical fraternity’s concerns about safety of drugs manufactured in India. Edited excerpts from the interview:

Question: Could you tell us about the NMC guidelines on generic medicines and how you think it will affect access to medication for Indians?

Generally, access to medicines depends upon the way in which the healthcare system is organised. The healthcare system in India is highly privatised. A very small minority go to public healthcare facilities, which are crowded and lack adequate facilities. About 33% ailments in rural areas and 26% ailments in urban areas were treated in government hospitals, according to the 75th round of the National Sample Survey (NSS). Further, the report also found that the percentage of cases of people undergoing treatment who received free medicines in rural India is 13.8% and 14.4% in urban India. Public healthcare facilities do not have adequate stocks of required medicines, so people are forced to buy medication from the market. We spend a lot out of our pockets for healthcare in general, and a substantial percentage of this is spent on buying medicines. As per the 2020 national health accounts, around 22.10% of the current government health expenditure is on pharmaceuticals. For a patient, the average medical expenditure per case of hospitalisation in a government hospital is Rs 4,837 and that in a private hospital in an urban area is Rs 38,822, according to the National Health Profile 2022. Out of this, medicine accounts for the largest share (Rs 2,100 in a government hospital and Rs 7,035 in a private hospital). This shows that while India remains the producer of medicines at the most affordable price, medicines are an important component of our healthcare expenditure. There is a need for the government to intervene.

People buy medicines based on the prescriptions, which are often in the brand name of the drug, not the generic name. The doctor decides the brand of the medicine on behalf of the patient. Nobody has the confidence to change that. But if you have a prescription based on the generic name, then the patient can choose an affordable brand. This practice of brand-name prescriptions makes the medical profession vulnerable to the marketing strategies of pharmaceutical companies. In other words, there is a threat of secondary interest i.e. the promotional strategies of the pharmaceutical companies, influencing the primary interest of providing affordable care to the patient.

In public health, it is also important that whenever a medicine is procured for free distribution, it is procured based on the generic name. If the doctor at the public health facility prescribes Dolo instead of paracetamol, then you may not be able to get it from the pharmacy [at the public health facility].

Against that background, we should look at the NMC guidelines. Prior to this new guideline, the Code of Medical Ethics 2002 stated as follows: “Every physician should, as far as possible, prescribe drugs with generic names and he/she shall ensure that there is a rational prescription and use of drugs”. The redacted part of the new regulation states: “Every RMP [Registered Medical Practitioner] should prescribe drugs using generic names written legibly and prescribe drugs rationally, avoiding unnecessary medications and irrational fixed-dose combination tablets”. Thus the new regulation took away the qualification and made it mandatory to prescribe using generic names instead of brand names. It is much more clear and straightforward now.

If the doctor prescribes a medicine using its generic name, there are some benefits. One is that the patient gets a choice to buy the lowest-priced medicine from a medical shop. Prices of these brands vary greatly. A study commissioned by the Competition Commission of India found substantial price variation ‘ranging from Rs 40 to Rs 336 for a pack of six tablets’ [of an antibiotic]. Doctors prescribing with brand names thus eliminate the patients’ right to choose affordable medicine.

Second, from a public health perspective, with the limited public health infrastructure that we have, procuring medicines for initiatives like the Jan Aushadhi Yojana is easier.

Third, a doctor anywhere can understand your prescription. That is why the Drugs and Cosmetics Act insists that the generic name of the drug ‘shall be printed or written in a conspicuous manner which shall be at least two font sizes larger than the brand name or the trade name’. And fourth, this will be better for public health because companies need not invest so much resources for building individual brands. This investment in brand building is reflected in the price of the product and if this price is too high, it will compromise access.

So just paying more money to buy a drug does not assure quality, is that what you mean?

A brand name does not assure any quality. Doctors cannot say that this brand is of good quality. That is a belief. There is no science behind it. This is similar to saying that a Samsung phone is good or an iPhone is good but there are cases of Samsung phones exploding while being plugged to charge. So the doctor cannot claim that the product is of good quality. The goodwill of the company leads us to believe that the product is of good quality, which may not always be true.

In India, the majority of these branded medicines which are off-patent are locally produced by small companies and marketed by big companies. Many companies source products from [Indian] contract manufacturers, and they produce and give the brand name of the big companies and then the big companies market it.

In fact, the Hathi committee recommended debranding, in 1975, some three-four medicines or three-four categories of medicines, but it was never implemented. Branding gets in the way of access, so instead of marketing each medicine as a separate brand, they can make the company a brand, or the manufacturer's name as a brand. Then you would have Sun's paracetamol, or Microlab’s paracetamol, or Cipla’s paracetamol, or Mankind's paracetamol, etc. That's good enough. If a doctor is concerned about the quality, he can tell the patient to choose between the companies.

Some have suggested that it may be better or easier to make it compulsory for the chemist to give the generic variant to the patient if they ask for it instead of mandating that the doctor prescribe the generic medicine. So in either scenario, the patient does not lose their rights but the pharmacist has to provide the generic drug instead of the doctor.

That is possible even now–the patient can go to the pharmacist with a prescription and the chemist or pharmacist says that I can give you the generic equivalent of this drug. Most of the time you quietly say no thank you and you take the prescription and go to another medical store. Why does this happen? Because you have so much confidence in the doctor. Brand substitution remains only in theory because of the brand-name prescription. From a public health perspective, a doctor should prescribe in the generic name because anywhere in the world the doctor would be able to identify your prescription. Otherwise, the brand you get in Kerala, you may not get in Delhi, which can confuse the doctor in Delhi.

So is there no difference between, say, Glimer the drug (for diabetes) that is marketed by Abbott, and its generic variant?

No, all generic medicines are similar to their originator’s version. You cannot make your own paracetamol, right? All paracetamol will be the same. It is as identical as 2+2= 4. Minor variations in the potency do not have health implications. For example, a 100 mg tablet you take may be between 98 to 102 or 105, it's allowable. Even then, the regulatory agency is supposed to ask the companies to take corrective measures. However, any major deviations from the quality specifications would result in direct intervention from the drug regulator. They will intervene when the deviation is significant enough to affect the health of the person adversely.

If the medicine is a 100 mg tablet and if it has only 80 mg or 75 mg, then there is an issue. Or, if the purity level is too far off the specification or if there is contamination- all those things interfere (with the action of the medicine). But if the label on the medicine strip or bottle is not as per the specification (of the drug regulatory authority), it is not a health hazard, so they will take some action, but they might not come down too heavily for this kind of infarction.

Do the drug regulatory authorities rely on news reports or patients’ complaints?

The media, patients, anybody can report. Hospitals may report. This is called a pharmacovigilance system. It should work, but in India we invest very little in the pharmacovigilance system. We need to build it because, in the absence of such a system, you have antimicrobial resistance (AMR) and other issues. If the prescription is in the brand’s name, you won't be able to maintain a very good pharmacovigilance system because then the reporting would be complicated because reports would be in the name of different brand names of the same drug. At times, the regulator issues a warning about a particular medicine produced by all companies, and the patients may not be aware that it is related to their mediicne. For instance, in the warning against the use of ranitidine products, the USFDA [United States Food and Drug Authority] used the generic name (ranitidine).

Can you tell us more about the pharmacovigilance system we have in India? What are the major regulatory bodies? Who else is involved in this?

The Pharmacovigilance Program of India (PvPI) has a history of only 13 years [It started in July 2010 under the All India Institute of Medical Sciences in Delhi and was later recast as PvPI in 2011] and functions under the Indian Pharmacopoeia Commission (IPC). The PvPI received 64,441 reports from the Adverse Drug Reaction monitoring centres and manufacturers, as per the annual performance report of 2018 -19, the latest version available in the public domain. There are only 270 monitoring centres all over the country. This is inadequate in a country like India. The CDSCO [Central Drugs Standard Control Organisation] is an independent mechanism that gets information on drugs in use. There is scope for strengthening it, making it more effective by introducing more human resources, financial resources, awareness creation, etc.

The IMA called the NMC’s guidelines on generic medicines “ill-advised” and opposed it. What are your thoughts about the concerns related to patients’ safety cited by the IMA in its statement?

The IMA’s statement has emanated from their panic about shifting to mandatory generic prescriptions. Brand-name prescriptions serve to protect their own business model which is built on profiteering and exploiting the patients. When doctors prescribe a medicine of a particular brand, they are basically endorsing that brand over other licensed products available in the market. It is also an open secret that pharmaceutical companies provide various sops to these doctors either through continuing medical education or financing medical education, conferences, gifts, etc. Previously, the IMA has come under criticism from various quarters, including the then union minister for health, for endorsing fruit juice of a particular brand in exchange for huge money. Packaged fruit juice are not considered healthy. Therefore the government should place people’s health above profits and commercial interests and implement the NMC Regulation in its letter and spirit.

With our knowledge of the history of modern medicine, we know that a small deviation here and there will not create a problem. Quality is always used by big companies to prevent competition, just like intellectual property laws.

Having said this, I am not saying that there are no quality issues. But we should strengthen our regulatory system to address that. Doctors cannot continue their practice of patronising a particular brand in the name of quality. Quality assurance and enforcement are the responsibilities of the government, not the doctors. If brand names were any assurance of quality, then there should not have been quality issues at all. India has the highest number of drug-resistant TB patients. There is AMR and there are adverse reactions to drugs. All of this happened despite doctors prescribing supposedly good quality medicine, right? Doctors prescribe irrational prescriptions and irrational combinations.

Has something changed about the drug regulations of late? How can you explain the export of contaminated cough syrup, produced by Indian manufacturers, that is suspected to have contributed to the death of many children worldwide?

We need to dig till we get to the bottom of that issue. We need to find where exactly the problem came from and address the problem. Through the results of a thorough investigation, we need to take measures to avoid repeating the problem. In the US too, every year big companies' products are recalled because of contamination or other issues. Whenever such an issue comes, we should be able to address it to avoid repeating the same incident. Therefore, we need to strengthen our health system and regulatory system with more human resources and more financial resources.

if you don't have transparency, it can create problems. But using the case of contaminated cough syrup to make a case against generic drugs sounds like selective use of this information. The best way would be to bring in more transparency in the overall regulatory system and make the information available to the public every time such things happen.

You said that it is the government's job to ensure that this is investigated. But to use the same example, in the investigation into the deaths of children who took contaminated cough syrup in Jammu, the case is still pending three years later. How will the trust of patients and doctors be restored?

As per my understanding, our drug regulating agency is not done with the investigation. In addition, the WHO [World Health Organisation] will also have some data. Both these organisations should work together to find out what really went wrong and to address that. Regulatory systems continue to upgrade themselves in order to avoid similar incidents.

What kind of measures do you think we need to increase accountability and improve safety standards overall?

These institutions are built and manned by human beings. There are actors, especially businessmen who may find loopholes, shortcuts or grey areas. The job of the regulator is to spot those grey areas and reduce the chances of such actors succeeding.

I think the core issues are that we lack human and financial resources and certain governance reforms that would give independence and enhance accountability, transparency, etc. It is not like these things are altogether absent. We make comparisons with the USFDA, which is by and large financed by the pharmaceutical companies' applications. That is a clear case of conflict of interest. At least our CDSCO is not financed by pharmaceutical companies. It is financed by the central government from the central government's budget. This maintains the integrity of public institutions. In the former case, your salary depends on the money you generate. That makes it a service provider. Here the governance is, in a way, better than that of the USFDA. We can have much more transparency, disseminate more information, find more details of investigations into incidents and the measures taken. This boosts confidence in the system. If you don’t communicate, it leaves room for rumours.

What can we say to a patient at a rural healthcare facility who is concerned about the quality of generic medicine procured for them?

The rural people go to public healthcare facilities. Here, the procurement of medicines happens in the generic name by the government after proper quality and safety checks. The site of manufacturing is inspected and the drugs themselves undergo quality tests. So there is no issue of safety when drugs are procured in public health facilities. We do have a good record of various state procurement agencies starting from Tamil Nadu, which was a pioneer in this field. Most of the other states’ procurement model is based on the Tamil Nadu model. In Gujarat and Rajasthan too, the system works well.

What legal actions or policy measures do you think are required to strengthen the existing mechanisms for quality control for pharmaceuticals in India?

There should be much more power with the CDSCO to regulate production and marketing of medicines. We require legal, governance and financial reforms to empower the CDSCO. But quality and access to the medicines should be the objective, not just quality. There is no point in insisting on high standards beyond what is needed as per the scientific evidence for safety and quality, with the only purpose of making it harder for generic drug makers to comply with the standards. More investment in the public sector healthcare infrastructure, including public procurement and distribution of medicines, can take care of a lot of the problems.

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