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Directive on licence only in generic name could end branded drug promotion and job loss for medical reps: Bal Pharma VP

Nandita Vijay, Bengaluru | Friday, October 19, 2012, 08:00 Hrs [IST]

The Union health ministry's recent directive to state drug licensing authorities on grant or renew of manufacturing licences only in generic names is expected to create a turmoil in the country’s drug manufacturing industry. It could see the end of brand promotion leading to loss of jobs for the medical representative community. Therefore, the impact will be severe and could eventually see the end of the industry, said Archana Dubey Mitra, vice president, Bal Pharma.

Further, the new directive could be the beginning of the end of one of the India’s largest industries which has been able to establish its credentials in the international markets with its branded generics. The sector has dominated the markets of America and Europe by posting highest number of US FDA approval for formulations plants worldwide. India has the highest number of US FDA approved plants outside US, she added.

The strong domestic base of branded portfolio was generated only by the solid expertise emanating from companies including Ranbaxy, Dr Reddy’s Labs, Sun Pharma, Lupin, Torrent, etc., to name a few. Hence this decision is appalling specially coming at a time when more Indian companies were gearing up to enhance their presence worldwide, pointed out Mitra in an interaction with Pharmabiz over email.

Furthermore, the industry has a large workforce of medical representatives to promote branded products. With the ensuing directive, companies will now look to reducing manpower and retrench this segment of the workforce.

Another issue is that it was the medical representatives who were engaged in updating information and imparting the required know-how on the benefits of a drug to the medical fraternity. The branded drug product promotion will not cease to exist. Even doctors will miss out on latest information on the drugs.

Due to establishment of various brands there has been a strong inherent trust in the patient towards the quality. Generic scenario will not give any choice to patient depending solely on pharmacies to dispense material. There could be chance of compromise on quality by unorganised sector, she said.

Industry already is facing pressures on the price control movement by the government and Supreme Court directives leading to further problem for the industry.

Bal Pharma also has a division to promote its branded products and looking aggressively to consolidate its presence in the branded market. “We feel it is not the right move and it was announced keeping the industry in the dark. Now it is a threat on the sector’s survival. The guideline is not yet clear and we feel some resolution should be possible to save the industry while making the drugs affordable to all, Mitra said.

Comments

samy krishnaraghu	Oct 30, 2012 2:39 PM
It is extremely good decision by the Govt. time to rethink our traditional approach on drug policy adopted by Govt. More and More this kind of policy decision required to save the industry and common indians....Dear ADM VP Sales your view is not up to the mark...

Clinical Research JObs	Oct 22, 2012 7:10 PM
Nice decision has taken by the Ministry, all the Medical representatives will be rescued.

CVS Murthy

Oct 19, 2012 8:19 PM

I agree with the comments. But we should also see how world over branded generics have slowly been replaced by generics like in new zealand, usa, almost many countries of europe like germany, uk. How can one jusify A cipro is better than B cipro or C or D. Infact all the generic companies have to develop product similar to the innovator brand, prove the bioequivalence to reference drug, manufacture in a gmp site. These are basic requirements without which no manufacturer is supposed to sell any where in the world. After this the only thing variable is the price. hence it is very wise move to just have a generic name. it will bring down the prices to patients and cost of healthcare will be affordable. we should look at billion people healthcare costs rather than 200,000 reps working in pharmaceuticals firms.

harshvardhan	Oct 19, 2012 10:58 AM
MOH should focus on strict regulations like grant of license (particularly new drugs, FDCs), post marketing surveillance, brand promotion activities, improve the level of pharmacy stores and should support positively to health industries rather than taking negetive decision withour consulting industries.

Jagmohan Rai Agarwal	Oct 19, 2012 10:03 AM
Madras and Uttaranchal High Courts have already held that grant or renewal of drugs under brand/trade name is beyond the scope of Drugs and Cosmetics Act I have been pleading this issue for the last about twenty five years.

RAJ VAIDYA

Oct 19, 2012 9:45 AM

As usual, the authorities have done the ridiculous. DOing such a thing, that too unannounced, which is bound to have a very strong negative reaction, will only lead to a rapid back-tracking, or long drawn out court battles. Each time the authorities do such ridiculous things, and then have to do an about turn. Looks like they probably do it on purpose, so that they can show the courts and the country that we tried to do it, but now the matter is sub-judice or strongly objected to.
It would be wiser to take small steps, one at a time. What is really necessary for our country is to have a BCS classification fro drugs, and then to iplement this concept (Bioavailability & Bioequivalence), in a phased manner, starting from Class IV drugs - i.e. those drugs which have low solubility and low adbsorption, and then slowly move towards Class III, etc. By doing this, we will come to the "true" Generic regime, wherein, ANY drug in the country will be a Generic equivalent, and thus will allow for