The current policy of price control which is aimed at providing quality medicines at affordable prices is stifling creative competition in the market with direct and indirect control on all the products. Hence it is high time that there need to be a shift from 'control' to 'development'. These were the some of the thoughts shared during the annual Indian Drug Manufacturers Association (IDMA's) 53rd Annual celebrations held in Mumbai recently under the theme 'If it is pharmaceuticals it is India'.

Speaking on the sidelines of the event Secretary Department of Pharmaceuticals Dr V K Subburaj informed Pharmabiz that a task force has been set up to look into the issues of private companies and the SMEs in the pharma sector for their upgradation. There is also a need to launch schemes for pharma technology upgradation as we are dependent on only China for import of Bulk Drugs. "Though drugs in India are lesser priced, medical device sector is an important area which need to be addressed as the cost of diagnosis is still not an affordable proposition for Indian population, more so, as the disease burden in India will increase by five times in the coming years, he added.

Industry experts voiced out the concern that there is an urgent need to propel SME sector by helping with soft finance for technological upgradation, compliance with GMP standards and setting up of the common or individual Effluent Treatment plants. The proposal for GMP upgradation is pending for a long time. Around 1000 SMEs will be benefited if the scheme is announced. Upgradation of SMEs to WHO-GMP standards would enable them to export their products and thereby increase their credibility.

While Drug Controller General of India Dr G N Singh stressed on the need of drug discovery and research, Pharmacy Council of India President Dr B Suresh asked for industry's intervention in pharmacy education to make it job oriented. Around 50, 000 B Pharm graduates pass out of colleges annually in India.

Joint Secretary Ministry of Health and Family Welfare K L Sharma explained that medical devices and clinical trials will have a separate set of rules and made it clear that ambiguities or issues surrounding Drugs and Cosmetics Act will be cleared very soon towards a transparent and objective regulatory regime to arrive at quality drugs and patient safety.

Among other issues discussed, it came to the fore that the most important requirement is to properly define what constitutes a 'New Drug' as a part of the draft Drugs and Cosmetics (Amendment) Bill, 2015. It was debated by IDMA that there are a few different definitions being used that differ according to which Rules or Regulations they refer to, such as New Drug under DPCO -2013 with two definitions, Drugs and Cosmetics Rules 122E, FDCs, Subject Expert Committee (SECs) all of them defining it differently. Hence there is an urgent need for a comprehensive definition for the industry and regulators to clearly identify the scope and intent.  

IDMA made a suggestion that the guidelines to drug inspectors for taking action against manufacture, sale and distribution of spurious and/or adulterated drugs as amended in 2009 be officially notified while amending the Act. The Act at present does not distinguish between wilful actions committed by unscrupulous persons and misinterpretation of Rules or provisions by genuine manufacturers in the normal course of their business.

Some of the major causes of concern are over -dependence for APIs on China and our declining bulk drug industry, contentious issue of SLA approved FDCs, proposed ban on PET bottles, NPPAs move on regulating prices among other issues. These issues unless addressed and resolved at the earliest may undermine the growth of the Indian Pharma Industry both nationally and globally.