| Date: |
28-04-2015 |
| Subject: |
Commerce ministry to talk to industry bodies to take a call on joining pharma regulator PICS |
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HYDERABAD: Small and medium-sized pharmaceutical companies are wary ahead of a meeting called by the government to decide whether India should become part of a multinational regulatory regime.
Stricter standards, many fear, could drive up costs and make them uncompetitive, but being a part of the new system could make it smoother for Indian firms to access lucrative export markets. The commerce ministry will talk to industry bodies on Monday about whether there is value in joining the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme, known as PICS.
The agency , now consisting of 45 drug importing countries, wants exporters such as India to comply with strict regulations to gain access to their markets.
The government had asked the Pharmaceuticals Export Promotion Council (Pharmexcil) to study the impact on the drug and a global agency appointed by the Pharmexcil for the study has recently submitted its draft report to the government.
Officials from the department of pharmaceuticals, the drug regulator, and executives representing Indian medicine manufacturers have been invited to attend the meeting on Monday , said PV Appaji, director general of Pharmexcil.
PICS, headquartered in Geneva, Switzerland, prescribes two international instruments for member countries and their pharmaceutical authorities for "active and constructive cooperation" in the field of good manufacturing practices.
A PICS committee has also resolved to expand its mandate from the existing manufacturing standards to new fields such as good clinical practices and good pharmacovigilance practices. Adhering to the new rules mean that Indian companies that export their drugs will be having one single regulatory body - PICS - for the procurement of drugs from any exporting country . However, small and medium size drug companies, especially those that only cater to the domestic market, would not support the idea of joining the global league as their units should be upgraded to global standards, which may result in expenditure of Rs 5 crore to Rs 20 crore per unit, according to a senior official of a mid-sized Hyderabadbased pharma company .
"Some of the member countries are asking us whether India is PICS compliant for procuring medicines for their government orders. Small countries which do not have regulatory expertise are insisting on it," Appaji said.
Source : economictimes.indiatimes.com
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