A high level meeting between the Union health minister Ghulam Nabi Azad and the captains of pharma industry will be held in Mumbai on September 4 to discuss various pending issues being faced by the industry. The burning issue of major Indian pharma companies being taken over by the MNCs will also figure prominently in the meeting.
According to sources, the union health minister's initiative in this regard comes after the persistent efforts taken by the Indian Drug Manufacturers Association (IDMA), seeking Azad's intervention to solve several long pending issues being faced by the pharma industry in the country. More recently, a delegation of IDMA had met the minister in Delhi, seeking his immediate intervention on several issues.
The one issue that will figure prominently is the takeover of Indian companies by MNCs. The promoters of some of the Indian companies like Piramal Healthcare, Ranbaxy, Shanta Biotech and Dabur Pharma have already sold their controlling shares to US, Japanese and German MNCs. There is apprehension that many other drug manufacturers are reportedly interested in similar disinvestments.
There is fear that this development will eventually result in MNCs gaining market supremacy and essential medicines are bound to become costlier. So, the Indian companies wanted the government to come up with policy options to ensure that major Indian pharma companies remain in Indian hands.
Another burning issue is the notification of guidelines attached to the Spurious Drug Bill which has been a long pending issue. The files regarding the issue is presently stuck up with the Union Law Ministry. The IDMA wanted the government to immediately notify the guidelines so that genuine drug manufacturers are not harassed by the drug inspectors by misusing certain provisions in the Spurious Drugs Act which came into effect on August 10, 2009, enhancing the punishment to 10 years imprisonment and a fine of Rs 10 lakh for production and sale of spurious drugs apart from making production and sale of spurious drug a non-bailable offence.
Similarly, the IDMA has been demanding to the government to remove the clause relating to the 'Patent status of the drug' from the Form-44 of Drugs and Cosmetics Rules on the plea that the clause on the patent status of the drug only favours the patent holder to delay the entry of a generic drug in the market. The IDMA pleads that since the DCGI is not the patent authority in India, the entry relating to patent status should be deleted from Form-44.
Another issue that the IDMA wanted the minister's attention is the FDC issue which has been pending for several years. The IDMA wanted the government to reconsider its order making clinical trials mandatory for all the fixed dose combination (FDC) drugs irrespective of the fact that many of them have been accepted as 'good' by the expert panel on FDC and which are in the market for more than 10 years.
The IDMA also wanted the minister's intervention on the issue of the proposed DCGI's visit to Mumbai once in a month to sort out urgent problems faced by the industry.