A joint study by industry Assocham and research firm RNCOS has pointed out that a team of 1,500 drug inspectors are insufficient to inspect about 10,000 pharma factories resulting in pharma products regulatory problems, especially in the US and Europe, thereby affecting exports.
India's pharma exports stood at $13.7 billion in 2014-15.
The study, titled "Focus on Quality Management in Pharmaceutical Manufacturing," says India, which ranks as the fourth largest producer of pharma products in the world, says strict regulations are a fait accompli for an industry that caters to public health.
"However much we may wish otherwise, the pharma sector is and will always remain one of the most regulated sectors all across the world for the sake of public health," Assocham secretary General D S Rawat said on Wednesday, while releasing the study.
Recently, Dr Reddy's Laboratories (DRL) was in the news after the US Food and Drugs Administration (US FDA) issued a warning letter on 5 November this year based on its inspection of the company's units at Srikakulam, Nalagonda and Vishakapatnam in Telangana and Andhra Pradesh, between November 2014 and March 2015.
In its letter, the US FDA said it "identified significant deviations from current good manufacturing practice for the manufacture of active pharmaceutical ingredients (API)." It gave time till 7 December to the company to file a response, according to DRL's regulatory filing to the BSE.
In response to the letter, DRL CEO G V Prasad said the company was in the process of shifting some of the products from these plants to other facilities and considering third party assessment for its plants, PTI reported.
The share price of DRL has declined sharply from Rs 4,252 on 5 November, 2015, when the US FDA issued the warning letter, to Rs 2,997.30, a fall of almost 30%. The price touched a 52-week low of Rs 2,953 intra day.
Latin America is an area that has emerged as a significant geography, with exports crossing $1 billion for the first time in 2014-15. The exports increased 12% to the region in a year that saw overall pharma exports increasingly by a modest 2.6%.