Govt announces new pharma policy

[Guest guest]

Govt announces new pharma policy

The government, on Friday, announced the pharmaceutical policy 2002

reducing price control substantially and exempting a drug with

turnover of less than Rs 100million from the control regime.

Laying down a two-tier criterion for regulation of prices the policy

spells out measures for boosting research and development by

exempting drugs developed indigenously. Moving towards decontrol

regime of drugs, the exemption limit has been raised to Rs 100million

from the earlier Rs 40million. A bulk drug will come under price

control if its total moving annual turnover (MAT) is more than Rs

250million and market share of manufacturer is 50 per cent or more.

According to the second condition, a drug would come under control,

if the total MAT value is less than Rs 250million but more than Rs

100million and market share of any of the formulators is 90 per cent

or more.

As per the policy, which was approved by the Cabinet on February 5,

new drug patented under Indian Patent Act 1970, developed through

indigenous research and not produced elsewhere will be exempt from

price control for a period of 15 years from the date of commencement

of its commercial production.

Similarly, a formulation involving a new delivery system, will be

eligible for exemption from price control in favor of patent holder

formulator from the date of the commencement of its commercial

production till expiry of patent.

It has, however, retained the same maximum allowable post-

manufacturing expenses (MAPE) at 100 per cent for indigenously

manufactured formulations.

PTI, February 15, 2002

Dr Dwijen Rangnekar

Senior Research Fellow

School of Public Policy

University College London

29/30 Tavistock Place

LONDON WC1H 9QU, UK

E-mail: d.rangnekar@...

_______________________________