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Compliance is the main mantra for regulators: Maharashtra FDA Commissioner

Yash Ved, Mumbai
Friday, November 22, 2019, 08:00 Hrs  [IST]

“Compliance is the main mantra for regulators,” said Dr Pallavi Darade, Commissioner, Food and Drug Administration, Government of Maharashtra.

Speaking at a seminar-cum- interactive meeting held in Mumbai recently by the Pharmaceuticals Export Promotion Council of India (Pharmexcil), Dr. Darade added, "We are in discussion with all the stakeholders on environmental clearance issues. We have also taken various measures on no objection certificate (NOC) making decentralised for pharma industry. Pharma exports have done well despite slowdown. We believe that the pharma sector will do well in future also."

The meeting was held to disseminate information to member-exporters of Pharmexcil regarding the proactive measures adopted by the government of India in promoting exports, to educate the members regarding the recent major changes in Incoterms, Iran trade business under rupee payment mechanism, etc.

Raghuveer Kini, executive director, Pharmexcil added that the seminar was organised basically to inform the members about the steps taken by the government of India for exporters and ease of doing business and also there is lot of scope for trade with Iran in pharma industry.

B N Vishwas, joint director general of foreign trade, Mumbai zonal office, said, "Basically, the current Foreign Trade Policy will come to an and end soon. The new scheme will replace Merchandise Exports from India Scheme (MEIS) and EPCG scheme. There are some changes in the new Foreign Trade Policy. The Union commerce ministry will soon formulate a new scheme, Scheme for Remission of Duties and Taxes on Exported Products (RoDTEP), to cover all export sectors under a framework for the refund of all un-refunded taxes or duties/levies, not exempted or rebated at present by any other mechanism. The new scheme is expected to substitute the existing export promotion schemes which are non-compliant with WTO. The contours of the proposed new scheme are being detailed out and will be notified separately after approval of the competent authority."

Manish Singhal, Assistant Drug Controller (India), Central Drugs Standard Control Organization (CDSCO) said, "The main vision of CDSCO is to protect and promote public health in pharma industry. The major function of CDSCO is to regulate control over the import of drugs, approval of new drugs and clinical trials, meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), approval of certain licenses as Central License Approving Authority is exercised by the CDSCO headquarters."

Charkravarthi AVPS, Global Ambassador, World Packaging Organisation and CEO, MD of Ecobliss India Pvt Ltd. added, "Healthcare sector is the largest maximum contributor to GDP. Packaging and labeling requirement in pharma sector is different for different countries. We should focus more on compliance issues. There were about 15-16 product recalls out of 80 products, which were due to packaging and labeling issue."


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