The Drugs Controller General of India (DCGI) has indicated that a slew of forward looking polices by the Union government that are expected in the next few weeks is set to transform the pharma industry and the start-ups landscape in doing business.

Specifically adopting the e:governance model, this would cover easy issue of licenses, faster export clearances for projects and speedy drug import approvals, among others. In principle, the government has increased its fund allocation to the Central Drugs Standard Control Organisation (CDSCO) by 25 per cent. Earlier this department worked in isolation and now the Prime Minister’s office (PMO) has insisted on a unified system of single window clearance regulatory approvals.

Some of these are new standard operating procedures (SOPs) interfacing CDSCO and state drugs control departments and use of information technology (IT) like internet and electronically networked systems would simplify the process to bring in complete transparency during drug approvals and issue of license.

The multiple systems of complexity that prevailed in doing business which impacted the pharma industry is now expected to witness a sea change as there would now be a huge difference in the functioning of the CDSCO, said Dr G N Singh, DCGI who was in Bengaluru recently.

“We are now in the final leg to put in place a process of working out the modalities that would support the pharma industry to market drugs either for domestic or international markets. Although we do not expect too much time for the last leg of approvals from the Union government, yet the wait would be worthwhile for the pharma industry,” Dr. Singh told Pharmabiz.

Now the office of the DCGI is the face of the pharma industry for clearing the regulatory hurdles. This is why we felt that only a significant transformation in the functioning of CDSCO could stall unnecessary delays which could mar the progress of pharma industry. The government has recognised the need for faster clearances and went on to allocate Rs.1,800 crore to the CDSCO. For the first time there is a dedicated allocation of Rs.750 crore to the state regulatory departments and this is a big boost to efficient functioning of these departments, he added.

The PMO has categorically asked the CDSCO to come out of the ambit of inspector raj era where cumbersome process led to inordinate delays. To this effect, the DCGI office made a presentation to listing out the SOPs to ensure minimum impediments. While these regulations would be tough to ensure high quality drugs are in the market, the use of IT would streamline the process of drug approvals and issue of licenses to bring in complete transparency, Dr Singh said.

“Further, there would be minimum interface and lucid interpretation of official notification and this would see the Indian pharma industry strengthen its global footprint. Currently, stringent regulated markets are recognising India as the pharmacy of the world and we need to sustain this image. Therefore a positive environment is on the anvil. Just like the IT, pharmaceuticals will drive the knowledge economy,” pointed out Dr. Singh.

“But unlike IT, for pharma the return on investment is insignificant. Now in order to accelerate the government’s commitment, we would look to encourage small-medium pharma entrepreneurs together encourage the start-ups in this sector to increase the upfront investments in sector,” he said.