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.