The Indian Drug Manufacturers Association (IDMA) comprising of around 700 drug manufacturers across the country, has sought Union health minister Ghulam Nabi Azad's intervention to solve several long pending issues being faced by the pharma industry in the country.
According to sources, the IDMA has sent letters to the minister seeking an appointment to apprise him on the issues being faced by the pharma industry like removal of the clause relating to the 'Patent status of the drug' from the Form-44 of Drugs and Cosmetics Rules, notification of guidelines on Spurious Drug Bill, taking over of major Indian Companies by MNCs, FDC issue and the proposed DCGI's visit to Mumbai once in a month.
The notification of guidelines attached to the Spurious Drug Bill 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.
IDMA also wanted to discuss the issue of the taking over of Indian companies by the MNCs, especially in the wake of the recent takeover of Indian company Piramal Healthcare by the multinational company Abbott at a fancy amount.
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.