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        Customs, DGFT & SEZ

        Government Committed to get Access to Indian Pharma in Key Markets: Suresh Prabhu

        May 8, 2018

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        Commerce & Industry and Civil Aviation Minister, Suresh Prabhu speaking at the inauguration of iPHEX, International Exhibition of Pharma and Healthcare

        Ministry of Commerce and Industry is fully committed to promoting the Indian pharmaceuticals industry globally, said Commerce and Industry Minister, Mr Suresh Prabhu, after inaugurating 'iPHEX' in New Delhi today. The 6th annual International Exhibition of Pharma and Healthcare (iPHEX) is being attended by over 650 delegates from 130 countries, including scores of regulators. The Minister said that Government is committed to promoting pharmaceutical exports to untapped markets, including China which has agreed for a high level bilateral Round Table to pave the way for Indian Pharma to get market access and penetration in their vast market.

        Shri Prabhu assured the global pharmaceutical players and regulators, of best quality and affordability of the Indian drugs. He emphasised the need for reaching out to newer markets, especially in Africa, where affordability is the key issue, which can be very well addressed by the Indian exporters. He stressed on the need of both competitive and complementary strategies, so that each segment of Pharmaceutical sector can benefit. He further said that there is need to make both traditional and preventive medicine, to work together.  He also said that Genomics is the new branch in medicine, which can play a major role for the Indian Pharmaceutical sector.

        Speaking on the occasion, Commerce Secretary Mrs Rita Teaotia said that effort is on to ensure uniform quality in the pharmaceutical sector. The Ministry is committed to ensure that consistent quality and efficacy is maintained by Indian pharmaceutical products.

        Enumerating the measures to improve Ease of Doing Business, the Drugs Controller General of India, Dr Eswara Reddy, announced increasing the validity of the GMP (Good Manufacturing Practices) Certificate, from two to three years. He further stated that protocol for clinical trials approval has also been changed, setting the time line of 45 days. Once approval does not come within this timeline, the protocol would have deemed to be approved.

        Chairman of the Pharmaceuticals Export Promotion Council of India (PHARMEXCIL) Mr Madan Mohan Reddy expressed confidence that the global business will be retained in India because of competitive cost of production. He complimented the Commerce and Industry Ministry for taking several measures to make India the main source of global manufacturing in pharmaceuticals.

        PHARMEXCIL Vice Chairman Mr Dinesh Dua said besides generics, India will soon emerge as a force to reckon with in the area of innovative drugs.

        Clinical trial approval timeline: deemed approval after the deadline to expedite regulatory certainty and market access. Regulatory reforms extend the validity of the Good Manufacturing Practices Certificate and establish a clinical trial approval timeline whereby an application not decided within the prescribed period will be deemed approved, aiming to reduce regulatory delay, ensure consistent product quality, and enhance export competitiveness for Indian pharmaceuticals.
                          Cases where this provision is explicitly mentioned in the judgment/order text; may not be exhaustive. To view the complete list of cases mentioning this section, Click here.
                            Provisions expressly mentioned in the judgment/order text.

                                Clinical trial approval timeline: deemed approval after the deadline to expedite regulatory certainty and market access.

                                Regulatory reforms extend the validity of the Good Manufacturing Practices Certificate and establish a clinical trial approval timeline whereby an application not decided within the prescribed period will be deemed approved, aiming to reduce regulatory delay, ensure consistent product quality, and enhance export competitiveness for Indian pharmaceuticals.





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                                ActsIncome Tax
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