Pharmabiz
 

iPHEX sees Indian pharma cos interacting with overseas regulators

Our Bureau, MumbaiThursday, May 22, 2014, 16:45 Hrs  [IST]

The second day of the iPHEX started off with a bang, with many exhibitors and delegates applauding the huge task of the iPHEX team, particularly the Pharmaceutical Export Promotion Council of India (Pharmexcil) for its commendable work.

The event today saw an interesting phenomenon, a trend setting seminar which saw Indian pharma companies and visitors thronging to meet the overseas regulators, to deliberate and discuss their doubts and get clarification on the regulatory norms adopted in the overseas market. A session was also dedicated to have a detailed analysis on the innovative potential of the Indian companies in developing new drugs and its potential in becoming lead global supplier of generic medicines ahead of China.

In yet another triumph to the Gujarat food and drug administration (Guj FDCA), when it comes to detecting drugs and pharma products of  ‘not of standard quality’,  Gujarat has earned a name for itself in leveraging technology and safeguarding healthcare interest  of  the consumers thanks to pro-active measures by the state regulator, Dr H G Koshia, commissioner, FDCA.

It was understood that Gujarat takes lead in ensuring safe drugs for patients; using SMSs for recalling not good quality medicine from chemists. While participating in the iPHEX, Dr Koshia said, “The moment a drug sample is detected of not of standard quality (NSQ), bulk SMSs are generated and sent to stakeholders, mainly the chemists, asking them to withdraw the relevant batch or batches of the concerned drug.”

Interestingly, the initiative of the Gujarat Government has also got appreciation from the DCGI and the Commerce Ministry, both stating that such a project should be used by regulators of all states.

In its presentation before the global media, including some journalists from Africa, CIS, LAC and Middle East which contributes about 60 per cent of India’s USD 15 billion exports, the CDSCO officials said that as much as Rs.180 crore would be spent on e-governance in the pharma sector.

With large resources being committed towards quality improvement by the Centre in cooperation with the state governments, the number of samples picked up for testing will increase from the present 50,000 to two lakh while 10 new laboratories will be set up in the next three years under the 12th Plan.

The CDSCO officials who have been interacting with buyers from 125 countries at the event said maximum efforts are being put to bring in harmonisation among regulatory regimes of different nations. If the patient is similar, medicine is similar, why should regulations not be simple, the question was debated.

 
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