From March 15, Mozambique mandated pre shipment testing of pharma exports, choosing to start with India, which is its largest supplier of pharma products. Ravi Uday Bhaskar, Director General, Pharmaceuticals Export Promotion Council of India (Pharmexcil) is all for the move. In fact, with Pharmexcil approaching more countries like Vietnam to move to this process, India’s pharma exporters should start planning in advance for similar mandates. He points out that the system is working very well in countries like Nigeria, as delays at the port of entry are avoided. This speeds up the export process, both for exporters as well as importing countries.
Some of India’s largest pharma companies, like Cipla, Glenmark and Ipca Laboratories to name just a few, are prominent exporters to Mozambique and other African countries. As per Ministry of Commerce data, pharma exports from India to Mozambique totalled Rs 91.5 crore of total exports of Rs 1000 crore, second to high speed diesel (Rs 757 crore). This includes retail sales of antibiotics and other medicines as well as tender-based sales of antimalarials.
The move has been in the works for some time now. Mozambique’s drug authority had flagged quality issues related to India-origin drugs in December 2016, around the time Vietnam’s drug regulator blacklisted 39 Indian pharma companies, who were allegedly exporting low-quality drugs. The African nation’s regulators issued a Ministerial Decree dated March 6, 2017 introducing the pre-shipment inspection and testing programme. The pilot project was launched on January 18, with the Ministry appointing Mumbai-based Quntrol Laboratories as the independent inspection and testing company to carry out pre-shipment inspection and quality testing of all pharma export shipments out of India.
Besides giving a sense of assurance to all stakeholders, Riddhi Javeri, Director, Quntrol Laboratories, lists one more compelling benefit of this process. With the Clean Report of Inspection and Analysis (CRIA), the pharma manufacturer/ exporter is assured that his shipment was as per required standards before it was shipped. This is important because if there is a problem with any part of his shipment after it reaches the importing country, the cause might lie with improper shipment or storage conditions as one of the reasons.
While pre shipment testing of pharma exports will involve some extra costs, like a one time non-refundable registration fee of Rs 20000 to register with Quntrol as an exporter, inspection fees per consignment, as well as some time lag, conforming to these quality standards can only burnish the credentials of individual pharma exporters as well as India Pharma Inc. With some advance planning, even smaller manufacturers/ exporters will be able to cope with the initial hiccups.
In fact, pre shipment testing could end up saving money as non-compliant consignments will be held back before shipping costs are incurred. Similarly, there is no uncertainty of goods lying in warehouses in the destination country, awaiting test results, especially in smaller countries which lack the regulatory infrastructure to deliver test results in time. All in all, a win-win mandate for all concerned.