CME INDIA Presentation by Dr. Akashkumar Singh,MD, MSc (Diabetes) FRCP (Edin) FACP, FICP, FRSSDI, FDiabetesIndia, FIACM, Vadodara, Dr, Anupama Ramkumar,MD Principal Consultant and CEO, Arkus Research Pvt Ltd., Ahmedabad, Dr. N. K. Singh, MD, Editor/Founder CME INDIA, Dhanbad.

Disclaimer: Interpretation of NMC draft by authors has been made to the best of their abilities and is not meant for any legal references. Readers are adviced to apply their own wisdom.

Reference:1

Key Points:

1. Medicines made by Pharma companies get a patent (MONOPOLY) to sell it for 20 yrs. Till this time, it is a PATENTED DRUG.

We can say “till the time its patent expires” (20 yrs. is from the date the patent application is filed. after filing, they have to do clinical trials etc, thus some molecules have about 10 yrs. or less or more since launch).

2. After this period, the patent expires & other companies can make and sell this drug, now called as GENERICS. (NMC has defined this as Branded Generics: is the one which has come off patent and is manufactured by drug companies and is sold under different company’s brand name).

Unlike USA, India is one country where we have Branded generics (brands sold by major Indian companies). Currently Generic-generics (with only name of drugs) are not freely available and constitute a very small market.

In our country since the last 5 yrs. or so, regulatory guidelines have become strict for branded generics.

For a drug class 2 and 4 (not easily absorbed for e.g., telmisartan) and is 4 yrs. old (marketed in the country), a company can launch it but they need to do a BE study. For a drug of class 1 and 3 (easily absorbed for e.g., paracetamol), there is no need for a BE study. and it is left to the individual pharma companies to ensure global quality standards. However, since our Food and drug control system is not very strong, it propels substandard Branded Generic drugs into the Indian Pharmaceutical Market.

For a FDC (fixed dose combination) which is first time launch, one has to do a clinical trial (phase 3) for approval (for e.g., Dopa plus Sita). And if companies would like to launch the above FDC and is not 4 yrs. old, they have to do a BE with the approved brand.

3. THE Branded GENERICS ARE CHEAPER than the patented drug BECAUSE of the following 2 main reasons:

A. The process to make it is now readily available. The huge money that went originally into research and development is now NOT needed to be put again by the companies wanting to make the generics.

B. The companies wanting to manufacture the generic drug are also free from the hassle of clinical trials (phase 1 to 3) to show the effectiveness of the drug in contrast to the innovator company which had to do the trials to get a licence when they made the drug originally. except for first time FDCs.

4. THE NEW COMPANY CAN SELL THEIR GENERIC DRUG IN 2 WAYS:

A. With a brand name, called Branded generics. (This could be deleted as it is dealt above)

5. The generic companies need only to provide evidence that their drug is similar to the patented drug in BIOEQUIVALENCE, meaning the generic drug has the same chemical composition and comparable bioavailability (i.e., how much the drug gets absorbed in blood after ingestion) as the original patented drug.

Once done, the generic drug gets a licence by the FDA to market the drug. This is what happens in the USA, UK and Europe and most regulated markets.

6. In India since 2017, Bioequivalence studies are required only for a limited drugs as clarified in point no 2. For a vast majority of drugs Bioequivalence studies are not required (I have shifted and modified one line in this paraph to the paraph below point 2)

7. So there is no way to know whether the Branded generic or Generic generic drug in India has the same quality and impurity profile as was in the patented drug. Also, for class 1 and 3 drugs, the rules do not mandate BE study.

there is no way to assess the bioequivalence of this drug in comparison to the innovator drug.  It’s on how much we trust the generic Pharma company.

8. Only few global Pharma companies sell their patented drugs in India. When their drug is off patent, they may sell them with the same or different brand name (called authorised generics). (In India, normally they will sell in the same brand name, we do not have the concept of authorized generics as of now) In such a case, at least the consumer knows that this is the original patented drug and so can be sure that the drug will be of good quality. Also, the big Pharma will not risk selling poor quality Branded generics.

9. The original company also discounts the price of their brand after the patent expires, so that they can compete with the new generic avatar.

10. FOR THE CATEGORY OF ‘PLAIN SIMPLE GENERICS

In the approved chemical name, called plain simple ‘generics’. NMC defines it as a drug product that is comparable to brand/reference listed product in dosage, in dosage form, strength, route of administration, quality and performance characteristics and intended use, with no brand name. Many small companies sell the generic drug with just the approved chemical name. Example, paracetamol is sold as paracetamol, not as Crocin or Dolo. These small companies do not have the same standards of manufacturing (not maintaining temperature, humidity, and such standards in these units), quality control, packaging, warehousing and distribution. The cheaper generic brands may also use substandard APIs (Active Pharmaceutical Ingredient – the raw material used to produce the medicine), to manufacture the medicines. They also bypass costly processes/steps in manufacturing the drug, thus producing a product which is far substandard than the good brands available.

Therefore, the formulation may not be at par with the required standards, the tablets may not be of equal composition, the stability of the drug might not be good enough for the shelf life as stated on the labels, the packaging may be of substandard quality and so on.

Obviously, they sell it in the less regulated markets of underdeveloped countries/poor countries where the enforcement of strict quality control is not prevalent. A tablet of 100 mg may contain less milligrams than the mentioned 100 mgs. So, the effect of such generic drugs in your body depends upon your personal luck

11. The National Medical Commission recently issued a notice in Aug 2023 that doctors must prescribe ONLY the approved generic name and not the branded generics

Decoding the NMC professional conduct Regulations of 2023.

• The National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023 came into force from the date of their publication in the Official Gazette, this month. They have caused quite a stir in the media and social media on some of the aspects.  Today as we delve into the clause of generic prescriptions which is the focus of a lot of current attention, let’s first set some of the background here.
• The professional conduct regulations are published in the Gazette, which means that they are rules that have the force of law and must be abided by. But the way the document has been written, it has about 11 Guidelines within this regulation that add a layer of ambiguity, as guidelines are generally recommendations and not necessarily enforceable. But as these are embedded within the regulation, they may as well be.
• A word on the L1/L2 mentioned at the end of several clauses in the official document. There are five levels of Disciplinary Action as per Breach of Conduct. The most commonly cited ones, i.e., L1 and L2 are as follows: –

Level 1: Reformation -This may be awarded singly or in conjunction with other levels, in the form of advisory, instruction or warning to be careful in future.

Level 2: This penalty may be awarded even when the role of the doctor in causing direct harm was not conclusively proved but the doctor was found to have breached any of the codes mentioned in the guideline. The maximum action is a suspension of the license to practice for up to one month (30days).

A. First who is a RMP for whom this professional conduct regulations apply?

Professional code of conduct applies to a “Registered Medical Practitioner” or “RMP”- a person whose name is either in the State Medical Register or the Indian Medical Register or the National Medical Register unless otherwise specified. The IMR is maintained by the Ethics and Medical Registration Board of the NMC.

The government of India has been promoting the Jan Aushadhi program (PMBJP) and the NMC regulations seeks to enforce it through the RMP. The regulations state “Every RMP should prescribe drugs using generic names written legibly and prescribe drugs rationally, avoiding unnecessary medications and irrational fixed-dose combination tablets. (L1 and/or L2).

The regulations allow the RMP to sell medications only to his/ her own patients. (L2). The word generic is not used here. The guidance states that the RMP can prescribe or supply as drugs, remedies, or appliances long as there is no exploitation of the patients. Drugs prescribed by RMP or bought from the pharmacy for a patient should explicitly state the generic name of the drug. (L2).

This means that all prescriptions must carry the generic name and not necessarily be the generic drug.

The guidance on prescription during telemedicine also does not use the word generic medicine but states that write clearly the name of the drug with clear mention of formulation, dose, duration and frequency.

The first of the 11 guidelines that are part of these regulations is the ‘GENERIC MEDICINE AND PRESCRIPTION GUIDELINES’ which in its preamble states the reason for the push to prescribing generics is to bring down out of pocket health care spends as generic medicines are 30 to 80 % cheaper than branded drugs and hence, prescribing generic medicines may overtly bring down health care cost and improve access to quality care. The guidance further clarifies the terms as follows-

Generic medicines vs Generic names:

Generic Name:

Non-Proprietary or approved name of a drug is also known as the generic name of the drug.

Non-proprietary name is the name accepted by a competent scientific body / regulatory authority.

Generic drug/medicine:

A generic drug is defined as a “drug product that is comparable to brand / reference listed product in dosage in dosage form, strength, route of administration, quality and performance characteristics, and intended use”

Branded Generic drug:

A branded generic drug is one which has come off patent and is manufactured by drug companies and sold under different companies’ brand names. These drugs may be less costly than the branded patent version but costlier than the bulk manufactured generic version of the drug. There is less regulatory control over the prices of these “branded” generic drugs.

Guidance to RMPs:

1. Prescribe drugs with “generic”/ “non-proprietary” / “pharmacological” names only.
   • In the case of drugs with a narrow therapeutic index, biosimilars, and similar other exceptional cases, this practice can be relaxed.
2. Prescribe drugs rationally and optimally.
   • Both overprescribing and under prescribing are to be avoided keeping in mind possible drug interactions.
3. Fixed-dose combinations are to be used judiciously.
   • Only approved and rational fixed-dose combinations are to be prescribed.
4. Advocate for hospitals and local pharmacies to stock generic drugs. Prescribe only those generic medicines that are available in the market and accessible to the patient.
5. Avoid prescribing “branded” generic drugs.
6. Encourage patients to purchase drugs from ‘Jan Aushadhi Kendras’ and other generic pharmacy outlets.
7. Educate medical students, patients, and the public regarding the equivalence of generic medicine with their branded counterparts.
8. Should actively participate in programs related to promotion and access to generic medicines.
9. MBBS & PG students will be trained in the value of prescribing generic medicine.
10. Written Prescriptions should be legible and preferably in full CAPITALS to avoid misinterpretation. As far as possible prescriptions should be typed and printed to avoid errors.

The guidance provides a template for writing prescriptions as follows-

Figure – 1:

As per the guidance – The words ‘must’, ‘shall / should ’and ‘may ’are used purposefully in these guidelines and indicate the degree of obligation that the doctor has to follow the guidelines. The word ‘must ’indicate a higher level of commitment and obligation required of the doctor, while in the case of ‘shall/should ’the level of obligation is less and there could be room for individual judgment.

Commentary :

• Our take on the safest way to prescribe Branded Generics in prescription. While prescribing the medication, follow the pattern of prescription listed below

Sample prescription to prescribe branded generics as per author’s suggestion:

Disclaimer: Interpretation of NMC draft by authors has been made to the best of their abilities and is not meant for any legal references. Readers are adviced to apply their own wisdom.

References:

1. https://www.nmc.org.in/MCIRest/open/getDocument?path=/Documents/Public/Portal/LatestNews/NMC%20RMP%20Conduct%20Regulations%202023.pdf
2. Joshi SS, Shetty YC, Karande S. Generic drugs – The Indian scenario. J Postgrad Med. 2019 Apr-Jun;65(2):67-69. doi: 10.4103/jpgm.JPGM_420_18. PMID: 31036775; PMCID: PMC6515776.
3. Generic Drug Facts. Fda.gov. 2018. [cited 2018 Apr 12]. Available from: https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/GenericDrugs/ucm16799 .
4. Andrade C. Bioequivalence of generic drugs: A simple explanation for a US Food and Drug Administration requirement. J Clin Psychiatry. 2015;76:e742–4

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