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THE GENERIC ORDER

P A Francis | Tuesday, October 23, 2012, 08:00 Hrs [IST]

Last week, the Union health ministry issued a directive to the health departments of all states and Union Territories instructing them to grant or renew licenses for manufacture or sale of drugs only in generic names. The state licensing authorities at the time of granting a product licence for drug formulations, the trade name as submitted by the manufacturer, is also endorsed along with generic name of the product. This practice thus gives legitimacy to market the drug under the brand or the trade name to the manufacturer. Now, effective implementation of the new order may enable patients to purchase low priced drugs in one therapeutic category with the advice of the pharmacists. Currently physicians prescribe company specific brands leaving no option to the patients or to the pharmacists to go for cheaper product in a therapeutic group. The intention of health ministry is to bring an end to the growing unethical practices in the pharmaceutical industry and trade. Brand promotion amongst the pharma companies is rampant today and doctors are being regularly bribed for the purpose. One of the main reasons for the high cost of medicine today is the increasing cost of brand promotion by the companies. Printing only the chemical or the generic name of the drug on the label makes it difficult to the companies to promote their products as they are doing now.

The Central directive is being strongly objected to by the pharma manufacturers as they think it is confusing and can therefore affect their operations. It is possible that some industry associations may think of challenging the order. No doubt, the directive is ridden with some administrative issues and there is no clarity on matters like the fate of brands for which licenses are already issued by various state authorities. Nearly a lakh of drug brands are already in circulation in the country and a majority of them are combination drugs. To recall all of them from the market and reissue licences in generic names is next to impossible. It will be extremely difficult to identify a drug combination by generic name as the chemical names are usually lengthy and confusing. A serious problem that can arise in the new environment is at the time of prescribing drugs by the doctors. Most of the physicians are not familiar with generic names of the drugs and errors can occur while prescribing drugs in chemical names. As most medical shops are managed by unqualified sales persons in the country, there could also be dispensing errors while handling prescriptions in generic names. It seems that these administrative issues have not been considered by the health ministry before issuing such an important directive.

Comments

jagaruk pathak

Nov 20, 2012 3:04 PM

The purpose is holy. But for Intravenous Immunoglobulin (IVIG), if you write as generic there will be lot of anomalies in products from EU, USA, China, korea etc. What will be a generic prescription for combination of Norfloxacin + ornidazole or three anti-TB drug or 9-10 Vitamin combination, or a pentavalent vaccine DTPw+Hib+Hepa-B etc. or in case of Medical device which is also defined as "Drug"

Naveen Gupta	Nov 12, 2012 5:57 PM
If DPCO and several time suggetions given by FMRAI (Federation of Medical and Sales Representatives Association of India) is implemented seriously the treatment cost will surely reduce drastically.

Anjali Virani	Oct 30, 2012 3:03 PM
It does not make any sense that most of the physicians are not familiar with generic names of the drugs. Is It difficult to write in prescription L+C+E or cand+H or Amlo+ateno ? Dispensing errors can be arised with similar brand names of two different medicines not with generic names.

vasi ansari

Oct 30, 2012 11:59 AM

I think it will create lots of health issues for patients,pharmacological effect of any drug is depend on its quality.quality in terms of raw material,process,people and logistic,if every body go for low price drug so it will difficult to maintain quality of medicine which will create bigger problem is such cases like TB ,cancer and other.
so any rule from government should not come only just to decrees pries of medicine.

Mahesh Bansal	Oct 30, 2012 11:24 AM
Better way for price control is that medicine put under DPCO. its not fare that brand name stop by the govt.

Harash Syal	Oct 30, 2012 6:17 AM
Decision is good if it can be effectively/properly implemented and help in reducing drug prices.

prbreddy	Oct 28, 2012 11:59 AM
this is good sign in getting value to pharmacist as they are only professionals to handle medicines correctly. We expect total Indian pharmacy shops should come into professionals control. Before implementing health ministry to resolve all industry confusions.

chetan madaan	Oct 27, 2012 11:18 PM
Its not fare for giving this order its beter to put drugs under D.P.C...so that the price of medicine should be in control i.e at lower cost instead of stoping the brands.in this way new generation which are planing thier future in pharma industry will not be possible.govt should think about some other ways to reduce the cost of medicenes.

Prasenjit Bandyopadhyay

Oct 26, 2012 6:47 AM

Sir,
I would like to add another 2 (two) extremely negative point about only generic prescriptions.
(1)The drug shops will definitely keep generic products of those manufacturers who will offer them more more and more lucrative schemes for maximum benefit by selling a single unit of medicines which may lead to quality compromise and the loss will be of the general people.
(2)Job loss of lakhs and lakhs of medical representatives, office bearers, factory workers, closure of c&f agents, distributors, stock points, carriers, unorganised and organised staffs of those establishments will be inevitable and if you count the family members of those as minimum four, then few crores of people will have to starve to death.
Policy makers should think in other ways to reduce drug prices than pushing crores and crores to death. Organisations like FMRAI ( Federation of Medical Representatives Associations of India), who are struggling to reduce prices of drugs for more than a decade, gave spe

Arvind Vijay	Oct 25, 2012 9:51 PM
to stop unethical practice price control must be formulated. This is the only way to end the competition.

Ashish Rajyaguru	Oct 25, 2012 6:51 PM
Good to know latest infor on Pharma regulation & new laws

Generic medicine	Oct 25, 2012 5:38 PM
This is going to open new doors of competition and ultimately consumers will benefit from it,,,

jagmohan rai agarwal

Oct 25, 2012 12:50 PM

Your editorial "The Generic Order" does not seem to be in order. My views supported with povisions of the 'Act' have already been forwarded to Mr. Suresh two days ago.

I reiterate that issue of manufacturing licence with brand/ trade name of a formulation is not within jurisdiction of Regulatory Authorities under the 'Act'. One can print trade/brand in addition to generic name on the label and continue promotion of its product as before.

Zarir Homi Charna

Oct 25, 2012 9:47 AM

Dear Mr. Francis
You have been kind enough to many of my articles in the past.
Everyone seems to be confused about thMOH's Directive on Generic Licencing. The D&C Rules is silent on issuing Licences in Brand name. Companies obtain Brand Names for each and every product from the Registrar of Trade Marks.
The Association of Small Manufacturers of Pharmaceuticals have deliberately confused issues of presciptions in Generic Names only etc deliberately to obfuscate the main issue.
Many of them market their Products in Brand names very similar to the Original Brand name of leading companies.
By getting such Brands endorsed on their Licences they try to get some legitimacy to sell such conterfeit products.
The DCGI has also made it clear to the relevant Committee of IDMA that this does not change anything. Regulatory authorities will issue licences in generic names, which is mandated by the D&C Rules and the brand names will continue to be printed on the cartons by the Brand owners. Ev