Emcure Pharma Gets US FDA Warning Letter; Indian Drug Industry Vows For Quality Excellence

Hardly a month after the Indian drug industry came out with a white paper on its aspiration and commitment for quality excellence, Pune-based drug maker Emcure Pharmaceuticals has received a warning letter from the US Food and Drug Administration for significant violations of current good manufacturing practices (CGMP) regulations.

The Pune drug maker’s Hinjewadi manufacturing facility that makes pharmaceuticals formulations or finished drug dosage forms, which was last inspected by the US drug in February 2015, has been warned against many specific violations observed by FDA investigators during this inspection.

The main violations include its failure to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products, poor aseptic processing techniques, poor sterilization practices and inappropriate design and qualification of equipment, the FDA said in its letter.

Emcure Pharma, promoted Pune-based pharma entrepreneur Satish Mehta, is currently one of the leading drug exporter and contract manufacturer. It also has significant presence in the domestic pharmaceuticals market. While the FDA is yet to ban exports of Emcure to US market, the regulator has warned the company to investigate and determine the causes of the said violations for preventing their recurrence, and preventing other violations.

And, the company has also been warned by the US regulator that until all corrections have been completed and FDA has confirmed corrections of the violations and the firm’s compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer. “In addition, your failure to correct these violations may result in FDA continuing to refuse admission of articles manufactured at Emcure Pharmaceuticals,” the FDA letter, reviewed by BW | Businessworld, said.

Since Emcure also manufacture drug formulations for other leading pharmaceutical companies from Indian as well as abroad, the US FDA warning is not only going to impact its own sales but all its principals, who exports their Emcure sourced products to the US as well.

Emcure is the latest to receive the US regulatory memo in India this year after several of its big and medium rivals in the country including Sun Pharma, Cadila Healthcare, Dr Reddy’s Laboratories among others in the last six months.

Regulatory compliance issue flagged by the US regulator has been on rise in India, a country which houses the largest number of US approved drug manufacturing plants outside the US, in the last five years as FDA has increased its surveillance here.

While, the leading domestic drug manufacturers, who mostly earn their larger portion of revenue from exports of generic drugs, especially to the US market, had recently come out with a resolution under the lobby group Indian Pharmaceutical Alliance (IPA) emphasizing industry’s commitment to quality.

The IPA white paper highlighted that India accounts for 60 per cent of global vaccine production, contributing 40 to 70 per cent of the WHO demand for DPT (Diphtheria, Pertussis and Tetanus) and BCG (Bacillus Calmette–Guérin) vaccines, and 90 per cent of the WHO demand for measles vaccine, reducing global healthcare costs. It also said that the low cost generic drugs from India were responsible for health-related savings of at least $254 billion in the year 2014 in the US.

According to latest IPA estimates, the share of products of Indian origin in US pharmaceutical sales increased from 18 per cent in 2009 to 33 per cent in 2014. But, at the same time, between 2008 and 2014, the number of product recalls and warning letters received by pharma companies globally tripled, the industry resolution said.

In India, pharmaceutical companies have had mixed success in upgrading their quality systems. The number of warning letters from US FDA to Indian manufacturing sites has increased in the last five years. While the number of inspections increased by 30 per cent in 2015, the industry continues to grow and expand in scale and complexity, it is crucial to pursue quality excellence relentlessly, it said.

The priorities listed in the IPA white paper included improvement data management and documentation, quality investigations, management systems with increasing operational complexity, quality culture across the organization, expansion of talent pool and embedding quality into product development and technology transfer.