CDSCO increases WHO GMP certificate to three years for ease of doing business.

In a move to improve ease of doing business, India is increasing the validity of the World Health Organisation (WHO) Good Manufacturing Practices (GMP) certificate to three years. The certificate was earlier valid for two years, said Drug Controller General of India Eswara Reddy during the 6th annual International Exhibition of Pharma and Healthcare (iPHEX) on Tuesday. 

The measure would also result in more product registration for exports, he said, adding that a key demand of the industry has been met. 

Likewise, the protocol for clinical trial approvals has also been changed by setting the timeline of approval at 45 days. Once approval does not come within this timeline, the protocol would deemed to be approved. 

Government is committed to promoting pharmaceutical exports to untapped markets, including China which has agreed for a high level bilateral round table to pave way for Indian pharma to get market access and penetration in their market, commerce and industry minister Suresh Prabhu said during iPHEX. 

Prabhu added that he had recently taken up the issue of market access and increasing Indian pharma exports with Chinese commerce minister Zhong Shan. 

"The Chinese commerce minister agreed for a round table so that the issue of market access can be addressed," he said . 

Prabhu said that pressure on policy makers to reduce pricing is a global phenomenon, including in the US. He emphasised the need for reaching out to newer markets in Africa, where affordability is a key issue that can be addressed by Indian exporters. 

The US accounts for over 30% of India's $17.25 billion pharma exports and India has the highest number of US FDA approved plants outside US, according to data from the Pharmaceutical Export Promotion Council (PHARMEXCIL). 

"Effort is on to ensure uniform quality. We take it very seriously and want to ensure that consistent quality and efficacy come out of the Indian products," added commerce secretary Rita Teotia. 

The size of the Indian pharmaceutical industry is expected to increase to $50 billion in the next few years from the present size of $32-33 billion, according to PHARMEXCIL chairman Madan Mohan Reddy.