The Pharmaceuticals Export Promotion Council (Pharmexcil) has asked the union health ministry to issue Good Manufacturing Practices (GMP) certificate for units making medical devices also as some of the countries, which are importing medical devices from Indian companies, are demanding GMP certificate as proof of quality of the product.
In a written communication to the Drug Controller General of India (DCGI) Dr Surinder Singh, Pharmexcil executive director Dr PV Appaji said that the council has received some representations from the pharma exporters stating that medical devices products like Hemia Mesh are required in Latin American and African countries and these countries including Puerto Rico are insisting for GMP certificate issued by the exporting country authorities as proof of the quality of the product.
Medical devices sector is a fast growing segment of health care products and exports of medical devices from India are growing significantly during the recent past some years. “In view of the need for encouraging exporters of medical devices and to achieve the ambitious goal of US$ 25 billion by March 2014 announced by the government of India, we request your kind cooperation and proactive clearances,” Dr Appaji in his letter to the DCGI said.
The Pharmexcil executive director also asked the DCGI to issue guidelines for manufacture and issue of GMP certificate for medical devices products.
So far, the GMP certificate is issued to the pharma units by the health ministry after comprehensive inspection of the units by the ministry officials. The GMP certificate is accepted as a proof of quality of the unit. But, the ministry is yet to introduce the system of issuing GMP certificate to the medical device industry.