Following the instruction of the Drugs Controller General of India (DCGI), the state licensing authorities (SLAs) in the southern states of Kerala, Tamil Nadu and the union territory of Pondicherry have stopped issuing licences to manufacture and sell pharmaceutical products with brand names.
The SLAs say that there is no mention about ‘brand’ in the Drugs & Cosmetics Act, so there is no need to issue licence for brand names.
The state drugs control director and licensing authority of Tamil Nadu said he has stopped issuing licences for branded products as per the order of the drugs controller general.
For licence to new drugs including fixed dose combinations (FDCs) will be issued on the approval of the DCGI, said G Selavaraju, the director of drugs control.
“We stopped issuing licences for trade names soon after receiving the order. Hereafter we will not issue any licence to the manufacturers of branded products. We will issue it only in the generic names. No licence will be issued to those come under new drugs category except on the approval of the DCGI”, he said.
M Rajkumar, the licensing authority and drugs controller in Pondicherry said he has stopped issuing product approvals. Licence to new products will be issued on the advice of the drugs controller general. Henceforth his office will issue licence to generic products only, the drugs controller of the union territory told Pharmabiz.
According to Rajkumar, the small scale units in the sector have to fight for survival. The new order will take away the brand names, so the big players also will struggle hard to continue. The situation will create big competition which may not be a healthy one, but the people will get benefit out of this.
The Kerala drugs controller C S Satheesh Kumar said he officially stopped issuing the licence for brand names on October 16. But he said even before the DCGI issued the order he had stopped it. His office was not issuing such licences. Those who wanted such licences were applying through the DCGI office previously.
In Kerala, the number of manufacturers of branded products are very few. Among the total 33 manufacturers in the state, 90 per cent of them are engaged in contract manufacturing. “So we don’t need new licences or licences for trade names”, said K P Purushothaman, president of KPMA.
Satheesh Kumar said there is no need to issue licence for brand names as the word “brand” is not mentioned in the Drugs and Cosmetics Act.
In the meantime, the chairman of the subcommittee of the Indian Drugs Manufacturers Association (IDMA) has contacted the DCGI, and had discussion on the crucial issue. Industry sources informed Pharmabiz that the DCGI gave assurance to the manufacturers that licence would be given on generic names, but the companies can print their own brand names on the products along with the generic name. So the market will have several products of a particular category of generic with numerous brand names. The industry is waiting for a written clarification from the DCGI in this regard, sources said.