Govt likely to permit NPPA to verify landed cost of drugs

03 Oct 2011 Evaluate

The drug price supervisory body - National Pharmaceutical Pricing Authority (NPPA) is likely to get powers to verify landed cost of drugs that are under its control. The government is mulling alterations to the drug pricing law to permit the NPPA to look for details of landed cost of medicines. Landed price refers to the cost of medicines when they reach Indian shores and the regulator fixes the price of these drugs on the basis of this.

The NPPA had approached the Department of Pharmaceuticals (DoP) requesting it to take up the issue with other ministries. Under current laws, the NPPA cannot fix prices of patented drugs and most imported medicines used for treatment of illnesses such as cancer. The scope of price regulation is further restricted because the Drug Pricing Control Order (DPCO) allows the regulator to only keep an eye on drugs made by using any of 74 named ingredients. About half of these ingredients are no longer being used.

It is reported that above 1,000 imported formulations are sold in India. A revision of the drug pricing laws will go a long way in reducing prices and bringing them within the reach of the poor. According to the Indian Pharmaceutical Alliance, current laws are tilted in favour of multinational firms as only domestic drug-makers are required to give details of how they have arrived at the cost of production.

As per government officials, changes and amendments are required to make drug price regulation more effective. The move is not to give draconian power to the watchdog or hamper the industry's growth but to make prices of drugs affordable and encourage indigenous production of medicines. However, experts from the industry feel that NPPA’s move would not be very useful, as several imported medicines fall outside the sphere of the control mechanism.

The drug price regulator had earlier this year tried to check details of landed cost when an American company sought a sudden ‘sharp increase’ in cost of production of its brand. But its move was shot down by a court after the Law Ministry approved that the NPPA did not have the authority. In 2005, India implemented a new patents regime, which gives 20 years of exclusive marketing rights to patent holders. To alleviate loss of revenue in their home markets, global drug-makers have launched a slew of their original drugs in India, mostly imported. Most of these drugs are expensive and beyond the reach of the masses.

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