Usha Sharma & Viveka Roychowdhary – Mumbai
Senior officials of the Ministry of Commerce, as well as head of CDSCO said that the regulatory reforms in the pharma sector would get priority attention as soon as the new government starts functioning. This includes deliberation on the recommended amendments to the Drug & Cosmetics Act as well as strengthening the regulatory mechanisms at both centre and state levels.
They were speaking on the sidelines of the three-day iPHEX 2014 event, orgainsed by Pharmaexcil, and supported by the Ministry of Commerce, Govt of India. Inaugurating the event, Gopal Shetty, Member of Parliament, gave his best wishes to the show and hoped that the different stakeholders would use the tiemt o discuss and work out their differences. Speaking for the new Narendra Modi-led government, he aausred the the industry that they would get all the support they asked for, both at the state and the centre.
The event was co-located with Pharma PRO & PACK, organised by the Indian Pharmaceutical Machineries Manufacturers’ Association (IPMMA). The show saw participation from 40 drug regulators from 20 countries as well as delegates from approximately 150 countries and 5000 pre registered participants.
Divulging more details of the regulatory reforms on the anvil, Dr G N Singh, DCGI, said, “Rs 3000 crore has been set aside in the 12th Five Year Plan, to improve the infrastructure, hiring more staff and capacity building of the drug regulatory mechanism over the next three years. We will be setting up a National Dug Regulator Training Academy in Hyderabad. In addition to training new staff, every drug controller will have to undergo training twice a year.”
The emphasis on training is aimed at changing the mindset and attitude of regulators. In this context, Dr S Eshwara Reddy, Deputy Drug Controller of India, CDSCO also mentioned that the designation would change from ‘Drug Control Inspector’ to ‘Drug Control Officer’.
On the issue of hiring more staff, the DCGI said that in the next three years, there are plans to ramp up staff strength from 1500 to 3000 at both the centre & state levels. Dr Singh also revealed that e-governance would become mandatory for all states, so that the process of getting manufacturing licenses and approvals would be streamlined and transparent.
“We are concerned with the safety, efficacy and quality of products. We are strengthening the regulatory system as part of the global harmonisation process and will be raising the standards. Within two-three years, we will see a sea change. We will have a robust regulatory standard which will be seen and envied by other countries. We are confident that our pharmacopoeia and monographs will be at par with others.”
At present, around 50000 samples are tested at the state level annually; the aim is to increase this to 2 lakh. 10 new drug testing laboratories will be added to CDSCO’s current testing capabilities, with each state having its own lab. Similarly, 10000 samples are currently tested per year at the centre and this will be ramped up to 90000. Currently, 3-5 per cent samples are Not of Standard Quality (NSQ) and the aim is to reduce this to three per cent.
As part of the process of raising standards and the global harmonisation process, the CDSCO and US FDA have already jointly organised four workshops for industry. Eight more workshops are scheduled to be held before October this year, encompassing two more topics.
Wishing the event all the success possible, Sudhanshu Pandey, Joint Secretary, Department of Commerce, Ministry of Commerce & Industry, Govt of India, said,” we will work together with different countries embassies, regulators, industrialists for the improvement of the Indian pharmaceutical industry.
An event like iPHEX 2014 will give us better results. We will ensure that this event moves to the next level each year. This is not just a business meeting for buying and selling. iPHEX was started to convey a much broader message and is part of a larger cause. We have taken the first step last year when we launched iPHEX; this year the second successful event is another small step and I am sure we will continue to take much larger steps in the future.” Dr P V Appaji, Director General, Pharmexcil revealed that IPEX 2015 was scheduled to take place from May 13-15. In addition, the first global edition of iPHEX will be held in Nigeria, Africa this year.