The government has decided to include a fresh set of guidelines in the new Drug Prices Control Order (DPCO), 2002, for the provision related to the power of the government to exempt any manufacturer from all or any of the provisions of the Order.

According to the new DPCO, a copy of which is with the Business Standard, the production of a new drug patented under the Patents Act, 1970 and not produced elsewhere if developed through indigenous research and development (R&D) for a period of 15 years from the date of commencement of its commercial production in the country can be exempted from the Order.

Similarly, a formulation involving a new delivery system developed through indigenous R&D and patented under the Indian patent Act, 1970, for the process patent involving the new delivery system from the date of commencement of its commercial production in the country till the expiry of the patent can be exempted from the price control.

Another provision that has been added is that any formulation, if its cost to consumer does not exceed Rs 2 per day, can be exempted from price control.

Also, the production of a drug in the country by a process developed through indigenous R&D and patented under the Patents Act, 1970, till the expiry of the patent from the date of commencement of its commercial production in the country by the new patented process, can also be exempted from the price control.

Other basic criteria under this provision like the number of workers employed, amount of capital invested, range/group and type of products manufactured and sales turnover have been retained in the new DPCO.

The pharmaceutical industry has been eagerly awaiting the announcement of the new DPCO.

But the Karnataka High Court has granted a stay on the operation of the new pharmaceutical policy and subsequently on the announcement of the new DPCO.

The government has now decided to move the Supreme Court against the stay order of the Karnataka High Court.