Usha Sharma – Mumbai
Senior officials of the Ministry of Commerce, as well as head of Central Drugs Standard Control Organization (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, organised by Pharmexcil, 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 time to discuss and work out their differences. Speaking for the new Narendra Modi-led government, he assured 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 GN Singh, Drugs Controller General (India), said, “Rs 3000 crores 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 train 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 Drug Controller General (India) (DCGI) said that in the next three years, there are plans to ramp up staff strength from 1500 to 3000 at both the Centre and 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 two 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, three to five 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 the industry. Eight more workshops are scheduled to be held before October this year, encompassing two more topics.
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Exhibitors feedback Even though the iPHEX show is only in its second edition, exhibitors and visitors had high expectations and this is reflected in the comments. Most support the show but hope for higher return on investment. BR Sikri, Director, ABS Mercantiles shares, “This year’s show has witnessed less number of participants compared to previous years. This can not be compared with other events like CPhI because over there people come to meet and exchange their thoughts. Whereas iPHEX is a platform for genuine buyers and sellers to come and meet and exchange their notes and do their real time business and I personally feel this is an attractive aspect of this event, which attracts buyers and sellers to discuss about their business and opens better avenue to do large number of business worldwide. NM Mehta, Managing Director, Newtronic Lifecare Equipment felt that the exhibition is a very good show but the timing (May) is not ideal since it is a vacation month in Mumbai. He puts down the lesser than expected footfall to this reason and hence suggests that April could be the ideal month for this show in the future. Other exhibitors like Sandip Mhatre, Group Managing Director, Thermolab Group say that while the exhibition met their expectations, in future they expect good number of decision makers to participate especially from the foreign markets. “This year we have registered less number of foreign delegates at our stall and limited number of business inquiries. This time we noticed that there were less number of Indian visitors which I anticipate will increase in the coming years. There are many exhibitions taking place in a year and I feel that it should be once in two years so we (exhibitors) can show something new and developed products to our clients and visitors,” he said. Others like SP Dharma, General Manager – Sales and Marketing (Packaging Machinery – Pharma and Food) Labindia Equipments say they received good footfalls during the second day of the event. They realised that delegates from Africa were less interactive and he suggests that Pharmexcil should give them dedicated time to meet exhibitors at their individual stalls. K Bhaskaran, Managing Director, Suntech TEKNOPA too felt that day two of the event showed better outcome in terms of business inquiries and visitors. In his opinion, now-a-days exhibitions have become the best platform to meet customers as well as prospective customers and moving forward they will use this platform. He felt that the organisers have done good ground work for this year’s show but he too suggested that this event should be held next year in April. Another explanation for the less-than-expected crowds at the show came from Karnik Parikh, Director, Pharmalab who noted, “Due to unavoidable circumstances of Lok Sabha elections, this year the event is ok. But I suggest that the organisers shift this event from May to little ahead ideally October -March in 2015. As this is a vacation period, most decision makers are out of town. For us, day two of the show was better and the busiest day throughout the three day show. Going forward I feel this is a new show and we have to support it to help this event grow better.” |
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 PV 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.