Assocham urges govt to accord clinical trials approval in 30 days

New Delhi, Oct 6 (UNI) An industry body today urged the government to reshape its clinical trial approval processes and accord approvals in a month's time.

Currently, in India, the pharmaceutical companies are subjected to different procedures for obtaining clinical trials which take a minimum of eight months time, whereas in countries like Canada, the UK, the US and Netherlands, clinical trials approval are accorded in a month's time, the Assocham said.

Assocham Senior Vice President Swati Piramal, who also holds a position of Director Strategic Alliances with Nicholas Piramal, has submitted a representation to Prime Minister Manmohan Singh in this regard.

Nicholas Piramal is spending more than Rs 500 crore in research and has field over 200 global patents. Similarly, there are many companies which are spending huge money and yet their cases are getting delayed inordinately, the Chambers said.

The things need to be corrected as domestic pharma companies spend thousand of crores on R &D to come out with most innovative medicines and life saving drugs, the clinical trial of which takes longer.

The representation points out that longer is taken for obtaining clinical approvals as domestic pharma companies are required to be subjected to long bureaucratic processes in Health Ministry and other relevant departments which delay the clinical trials.

Its serious implication is that the competitors of domestic pharmaceutical industries take advantage as it is difficult to keep pharmaceutical innovations confidential.

The Chamber has also urged the Prime Minister to also allow Pharma companies to hike them prices of non-schedule drugs by 20 per cent each year in view of rising input costs.

The Chamber representation states that what is even worse is that the Ministry of Chemicals and Fertilisers is threatening the industry by bringing non-scheduled drugs under price control even when there is healthy competition existing in those individual cases.

The representation further points out that if this hostile attitude of the government continues towards pharmaceutical industry, many more MNCs would devour the domestic pharma units just as Ranbaxy was recently taken over by a Japanese MNC.

It has suggested that price increase of drugs under price control should be linked with inflation and within fixed time line of two weeks period.

Stringent actions should also be taken for schedule M compliance by all drug manufacturing companies as required by the law as the non-compliance is leading to a flow of large scale sub-standard and spurious drugs in the country.

The Chamber is of the view that Indian pharmaceutical industry is facing major hurdles to its growth both within India and globally.

Undue regulatory pressure is further frustrating the domestic pharma to such an extent that if immediate corrective measures are not taken, many life savings drugs are likely to go out of production.

UNI AK SG ND1818