IMA Stand on generic drugs

We all prescribe generic drugs only, where is the confusion then? (Part 1)

Dr KK Aggarwal

National President, IMA

The final IMA Stand on generic drugs

·         Write Legible

·         Write Generic (Generic- Generic or Trade Generic or Branded Generic)

·         Write Chemical name of the drug in CAPITAL (up to two drugs if combination)

·         Write NLEM (Counsel the patient, if writing non NLEM)

·         Write the rational (most economical and of quality) brand (in bracket, not in capital)

·         Non-scheduled drugs, include them in advisories and scheduled drugs in Rx

Followed by other details

Advice 1.      PARACETAMOL ( Calpol) 500 mg SOS 2.      Diet as advised 3.      30 minutes of brisk walking daily

Rx 1.      Tab LOSARTAN ( Losar) 50 mg at 8am 2.      ATENOLOL 50 + AMLODIPINE 5 mg (Aten AM) 8pm 3.       METFORMIN ( Metlong) 1000 mg at bed time 4.      A 2 Z one at 8pm daily

The NLEM List is available at http://cdsco.nic.in/WriteReadData/NLEM-2015/NLEM,%202015.pdf

IMA Stand in detail

1. What is the difference between branded and generic drugs?

·         Branded drugs: These are drugs sold under a trade mark within the validity of patent life by the innovator or their licensee. Hardly any Indian drugs are available in this group. Most are international company patented drugs.

·         Generic drugs: This nomenclature of a drug is adopted post its patent expiry.  

o    In an RTI reply MCI has admitted that it does not have the definition of generic drug.

o    It is also not defined under Drugs and Cosmetic Act 1940 and rules thereafter.

o    Under drugs and cosmetic rules, section 96, which specifies manner of labeling “the procedure of the drug shall be printed or written in a more conspicuous manner than the trade name.”

o    As per US-FDA, generic drug is a drug that is comparable to a brand in dosage form, strength, route of administration, quality and performance characteristics and intended use.

o    WHO: Generic version of a drug means a pharmaceutical product, usually intended to be interchangeable with an innovator product that is manufactured without any license from the innovator company and marketed after the expiry of the date of the patent or other exclusive rights, under a non-proprietary name rather than a proprietary or brand name.

o    In simpler terms, generic medicines are off patent drugs which can be sold by any pharmaceutical manufacturer without any license from the original manufacturer.

2. How are generic drugs marketed in India?

In India, a generic drug is available in three versions.

·         Generic-Generic or Generic only version (sold under chemicals / salt name only. Mostly for institutional supply. As multiple companies market or will market this version, we will have to write the name of the company in bracket to ensure quality (e.g. Jan Aushadhi).

Definition as per DPCO para 2 (j): generic version of a medicine means a formulation sold in pharmacopeial name or the name of the active pharmaceutical ingredient contained in the formulation, without any brand name.

·         Trade Generic Version (Generics sold under a trade or brand name). They are not promoted by the company and left to retail channel to sell these products. These are supplied to retailers at extremely low prices while printed MRPs are high (high trade margins).

·         Branded Generic Version (Generics sold under brand names). These are promoted by the company through medical representatives; doctors are incentivised to prescribe branded generics and enjoy 90% of the market.

·         Jan Aushadhi Generic-Generic Drugs (here the word Jan Aushadhi is the brand). For example, Jan Aushadhi or drugs under similar stores are the examples. For example, PARACETAMOL (Jan Aushadhi)

3. Are there any other differences in these versions of generic drugs apart from their MRP?

The cost of manufacturing is same whether Branded Generic, Trade Generic, Generic- Generic or Jan Aushadhi Generic-Generic.

All four versions have same active ingredient (s), same route of administration, same dosage form, same strength and same conditions of use as branded drugs.

4. Can a pharma company make all versions of generic drugs?

Yes, a single company can market one, two, three or all versions. If a company is producing all versions they will have the same ingredient, same quality but variable prices.

Generic only version can be made and marketed by local generic pharmaceutical companies as the only preparation. Similarly, local state companies can market trade only version of generics.

Jan Aushadhi generics are procured from top companies of the country.

5. Is Generic name of the drug same as the generic version of a drug?

No, the generic name of a drug is not the same as generic drug. It only signifies the name of chemical salt n the drug.

6. Can you give few examples?

Example Cetirizine, 10 mg, tablet

Scheduled drug, item 3. ix

Ceiling price fixed by NPPA 1.99 per tablet

As on May 2015 sold in 84 brand names (generic and brand)

Let us take one example of Cipla, brands marketed

·         CETCIP 10 mg: MRP/ tab 0.3125, Retailer prize 0.250 with margin 25% for 100 pack size

·         Cetcip 10 mg: MRP/ tab 2.016, Retailer prize 0.2532 paisa with 700% margin, pack size 10

·         Okacef 10 mg: Pack size 10, MRP 2.016/ tab, price to retailer 0.250 paisa and 706.40 % trade margin

·         ALERID 10 mg, Pack size 10, MRP 2.016 per tab with 1.536 Rs price to retailer and 31.25% margin.

·         Jan Aushadhi Cetirizine 10 mg: MRP 40 p / tab

The branded version which is promoted through doctors is Alerid and costs Rs 2/- to the consumer.

In case of Jan Aushadhi the margin is going to the consumer.

Hospitals and medical establishments who own pharmacies are likely to buy Cetcip or Okacef and likely to sell at the rate of Alerid to get 700% margin.

Hospitals may substitute brands from branded generic to trade generic.

Similar things are likely to be done by chemists if they are allowed to substitute drugs.

For practical purposes, trade-generics are the drugs purchased at generic-only version price, but sold at branded generic price rate.  

7. What are draft Drugs and Cosmetic Amendment Rules 2017?

These rules may be called the Drugs and Cosmetics (______Amendment) Rules, 2017 and are applicable for the labelling of a drug.

In the Drugs and Cosmetics Rules, 1945 (hereinafter referred to as the said rules), in rule 96, in sub-rule (1), in clause (i), in sub-clause (A), for the portion beginning with the words “For this purpose” and ending with the words “name and shall be”, the words “For this purpose, the proper name of the drug or fixed dose combination drug other than fixed dose combinations of vitamin and other fixed dose combinations containing three or more drugs, shall be printed or written in a conspicuous manner which shall be in the same font but at least two font size larger than the brand name or the trade name, if any, and in other cases the brand name or the trade name, if any, shall be written in brackets below or after the proper name and shall be” shall be substituted.

The above draft rules were put on public domain on 31^st March 2014 for comments within 45 days. The very fact government is amending this clause means they have no plan to ban trade or branded generic drugs.

The very fact that the government is planning labeling change with chemical name in big font and brand name in brackets in small font, easier will be to write similarly in prescription the name of the salt in capital letters and the name of the brand in lower case in brackets. 

8. What is the generic drug market in India?

No	Class of Turnover	Sales Turnover @MRP	Sales Turnover @PTS	%   of  Total Turnover	Margin to  Trade	Margin as %  of Turnover at MRP
		Rs Cr	Rs Cr	%	Rs Cr	%
I	Branded Generics	114,660	88,200	96	26,460	23
2	Trade Generics	13,300	3,800	4	9,500	71
3	Total Market	127,960	92,000	100	35,960	28

Source: Pharmatrack, Feb 2016 MAT

9. What does this mean?

As may be seen from the above table, the "high trade margin” relates only to 4% of the total market. The average margin to trade on this segment of Trade Generics is 71%, though there are instances of much higher margins being offered by a few companies.

10. IMA has recently analyzed the price variation of trade and brand generics available for common life- saving antibiotics and some anti-cancer drugs in the market in one of the pharmacy located in a hospital set up. What were the results?

A:  IMA found huge variations in the MRP

Antibiotic drugs

Name of the Drug	Dosage	Minimum MRP (Rs)	Maximum MRP (Rs)	Total vials sold in one pharmacy	Vilas Sold	Vilas sold
Piperacillin and Tazobactam	4.5 gm	200/-	1057/-	15329	MRP < Rs <500 (4354)	MRP > Rs 500 Rs (11038)
Meropenem	1 gm	592/-	2800/-	6801	MRP < Rs 1000 (1254)	MRP > Rs1000  (5647)
Cefoperazone and Sulbactam	1.5 gm 1 gm 3 gm	145/- 129/- 300/-	518/- 570/- 949/-	2733	MRP Rs < 300 (1166)	MRP > Rs 300 (1567)
Imipenem and Cilastatin	500 mg	549/-	1630/-	1410	MRP RS <1000 541	MRP > Rs 1000 969

  

Anti-cancer drugs

Name of the  drug	Dose	Minimum MRP Rs	Maximum MRP Rs
Docetaxel	20 mg 80 mg 120 mg	3300/- 10200- 14000/-	5529/- 21111/- 15378/-
Paclitaxel	30 mg 100 mg	1580/- 4676/-	1735/- 8076/-
Gemcitabine	200 mg 100 mg	1332/- 6201/-	1370/- 6267/-
Peg filgrastim	6 mg	10990/-	17900/-
Pemetrexed	100 mg 500 mg	3800/- 16500/-	73660/- 73660/-
Oxaliplatin	50 mg 100 mg	2537/- 5000/-	3143/- 10448.50/-

11. What is quality assurance?

In practice, the first concern for a doctor is quality assurance. WHO has set comprehensive guidelines in quality assurance for manufacturing and or marketing of all versions of generic drugs. These include guidelines for good manufacturing practices (GMP), inspection, product assessment and registration, distribution, quality control, laboratory services, and international trade in pharmaceuticals.   

12. What about bioavailability and bioequivalence studies?

These are the most important clinical parameters for a drug’s clinical response. Only on 3^rd April 2017, the health ministry has made bioequivalence studies or tests mandatory for all drugs before they are launched in the Indian market. 

The generic version or the trade only versions manufactured under state licenses might not have ever conducted bioequivalence studies.

Companies making all three versions of generic drugs may be following these guidelines but the generic only or the trade only version pharmaceuticals, mostly local start-up companies through the state licensing system, may not comply with these guidelines.

13. What are Jan Aushadhi dugs?

For providing quality medicines at affordable prices for all, Pradhan Mantri Bharatiya Janaushadhi Pariyojana, has been started on a self-sustaining business model with BPPI (Bureau of Pharma PSUs of India) now an independent society under the Societies Registration Act, 1860 as the implementing and the quality assurance body.

These drugs are sold under the generic only names but are not available in the market unless we write the word Jan Aushadhi in bracket. For all practical purposes, Jan Aushadhi is a brand.

14. Is the Jan Aushadhi concept a viable concept?

Unfortunately, this initiative so far has not picked up and has not addressed the purpose for which it was launched since there were few takers.  To support the concept, even IMA has opened a Jan Aushadhi Kendra at its head-quarters at Delhi and even passed a central council resolution that all state or local branches with IMA buildings of their own should open such units. The head quarter centre is till today not sustainable.

(To be contd…)