The office of the Drug Controller General of India (DCGI) may consider recommending the Drug Technical Advisory Board (DTAB) and other government agencies involved in a proposal from the industry circles to lower the new drug approval period from the existing four years to two years.

Aswini Kumar, the DCGI is learnt to have told a high level delegation of industry circles in Chennai yesterday that he would favourably consider their proposal after reviewing various aspects on the existing norms related to new drug approvals in the country.

Sources told Pharmabiz that if implemented, the move could considerably reduce the prices of new drugs, benefiting millions of patients in the country. At present new drugs have been monopolized by large-scale drug manufacturers, who charge higher prices for these drugs. When more manufacturers were allowed in the fray, competition could cause to reduce the drug prices, besides substantially reducing the manufacturing costs of small and medium scale manufacturers who venture into production of these drugs, noted sources.

At present, any new drug introduced in the country through either copycat versions or original invention is treated as a new drug for a period of four years. The DCGI's approval is required for any company to manufacture or market the drug in the first four years. This mandates companies to approach the DCGI's office for manufacturing and marketing approval for new drugs, during the four-year period when the drug is under the scanner of DCGI for its Adverse Drug Reactions (ADR) and other side effects. After the four-year period, the state drug controllers can allow manufacturing and marketing of those drugs, provided the drug is found safe and effective.

Sources pointed out that most of the companies, which launch these products, would inform the government authority only on the positive aspects of the drug during the surveillance period, which in effect makes this rule ineffective. The rule forces most of the drug manufacturers, especially small and medium pharma companies to approach the DCGIs office in New Delhi, instead of a much more quick and easy approval through their respective state drug controller's office.

If the government gives nod for lowering the period to two years, it could not only reduce the workload of the DCGI's office, but also benefit numerous small and medium scale manufacturers, noted the sources. With the new patent regime round the corner, this arrangement could be a short term strategy to benefit numerous small and medium level manufacturers in accessing numerous relatively new drugs, sources pointed out.