NMC Guidelines - Is It Branded Vs. Generic Medicines Or Branded & Generic Medicines?

NMC Guidelines - Is It Branded Vs. Generic Medicines Or Branded & Generic Medicines?

A few days back I heard a very interesting conversation at a webucational session organized by PharmaState Academy. The conversation led by Gauri Chaudhari ended with Gauri Chaudhari saying it should be ‘BRANDED & GENERIC MEDICINES’. I fully agree with her.

The major issue influencing the NMC decision is the price of branded medicines. The NMC Gazette nowhere talks about the quality of medicines produced, only generic prescriptions without understanding the complexities involved.

In the first place are our Indian-branded generic medicines really expensive in relative terms?

Here are the comparative costs of products in India as compared to the costs in neighboring Bangladesh.

The prices picked up are from top-class equivalent companies in both countries. They have similar manufacturing facilities and stringent QA/QC norms.

1. The leading brand of omeprazole 20 mg capsule in Bangladesh costs BD Taka 6.00 (INR 4.53) per capsule (Sourced from MedEx - https://medex.com.bd/) while Omez costs Rs. 2.18 (at 1 mg - https://www.1mg.com/)

2. The leading brand of amlodipine in Bangladesh costs BD Taka 3.00 (INR: 2.26) (Sourced from MedEx) while Stamlo costs Rs. Rs. 1.90 / tab (at 1 mg).

3. The leading brand of domperidone in Bangladesh costs BD Taka 3.50 (INR: 2.64) (Sourced from MedEx) while Domstal costs Rs. Rs. 2.11 / tab (at 1 mg).

4. The leading brand of ciprofloxacin 250 mg in Bangladesh costs BD Taka 8.50 (INR: 6.46) (Sourced from MedEx) while Cifran 250 mg costs Rs. 2.3 / tab (at 1 mg)

5. The leading brand of paracetamol 500 mg in Bangladesh costs BD Taka 1.30 (INR: 0.98) (Sourced from MedEx) while Calpol 500 mg costs Rs. 0.80 / tab (at 1 mg)

That the Indian branded generics are very costly and unaffordable is only a fallacy.

This apart, if the NMC gazette of 2nd August has to be fully implemented, the deciding authorities need to look at three important aspects that should be foolproof.

First, at the manufacturing level. Schedule-M or WHO-GMP?

Schedule M is the Indian GMP for the manufacture of pharma products.

If you study the paper “Comparison of Guidelines of Indian GMP with WHO GMP” written by Dr. Uma Vasireddy, M. Pharm, Ph.D., Professor and Principal, KIPS India, she has beautifully brought out the nuances between the two. (Source: Microsoft PowerPoint - Summit Presentation - Final (omicsgroup.com)

She concludes: “While complying with the WHO GMP requirements, the Schedule M has incorporated additional requirements as per the Indian experience and legal status and thus Schedule M is found to be more stringent than the WHO-GMP Guidelines.”

“However, the Indian GMP, like the WHO-GMP requires continuous updating of the GMP requirements as per changing trends in GMP Globally.”

Then why do our authorities want to accept the less stringent WHO-GMP which is not even acceptable in countries like the US, the UK, Japan Australia, and many more pharmaceutically developed countries?

Second, at QA/QC facilities in every manufacturing unit.

Do all the manufacturing units in our country have full-time QA/QC personnel? Especially those in the ‘earlier SEZs’. This is what the DoP and DCI inspectors must thoroughly investigate and present a report to the public of India.

Schedule M says “Sufficient number of personnel must be present to perform as well as supervise the manufacture, processing, packing, and holding off every drug product. In any pharma unit, it is important to lay out individual responsibilities in a manner that is clear enough to be understood by the personnel who are to perform the respective tasks.?Personnel is the backbone of the manufacturing unit, and there must be a sufficient number of adequately qualified and trained staff to ensure one achieves the desired quality products. No person should be so burdened with responsibilities that it presents a quality risk.” (Source: Organization and Personnel In Pharmaceutical Quality Assurance (solutionpharmacy.in))

Third, at the level of retail pharmacies.

For dispensing generic medicines, every pharmacy in India should have a full-time pharmacist. The sale of medicines should be made in the presence of a registered pharmacist during working hours. (Source: How to Open a Medical Store or Pharmacy in India? (cleartax.in)

A couple of years back, before the Covid-era, a patient came with a prescription for Arip-MT, an anti-psychotic medicine, aripiprazole. The next-door pharmacist did not have Arip-MT. He asked if the patient has a used strip of Arip-MT. the patient showed it. He then realized it was aripiprazole. “I don’t have that,” he told the patient,” But I have from another company something very similar,” and showed him omeprazole. ?He added, “That is a tablet, and this is a capsule and that’s the only difference.”

Everything was happening in my presence.

I stopped the qualified pharmacist from doing that. I took him aside and told him the reason why. He looked surprised. He said: “I thought omeprazole, rabeprazole, aripiprazole, and pantoprazole are all the same?”

If this is the level of pharmacists we have, they may easily replace a cefotaxim for cefaclor, or a cefuroxime for cefadroxil. This danger lurks.

All these three aspects must be strengthened and made foolproof by the DoP / DCI before a final call can be taken by the NMC Gazette for Generics to be implemented.

Then it can truly be ‘BRANDED & GENERIC MEDICINES’ as in the USA or Canada.

Gauri Chaudhari PharmaState.Academy?

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