Finally, Indian pharmaceutical industry scores on compliance with USFDA

2018 saw remedial work finally bearing fruit

After years of struggle, the Indian pharmaceutical industry finally got many things right in 2018 with the American government’s drugs regulator.

Not only did inspection outcomes improve, far more in line with global outcomes. The number of cases where the Food and Drug Administration (FDA) there chose to classify a production unit here under the 'Official Action Indicated' (OAI) category fell sharply. 

From 27 cases of OAI in 2014 and 22 in 2017, the number shrank significantly to seven. After an inspection, the FDA classifies a plant as either OAI, VAI (Voluntary Action Needed) or NAI (No Action Needed). 

This change came even as FDA-registered drug facilities rose 63 per cent in India between 2011 and 2018. In comparison, there was a 51 per cent increase in China, of 25 per cent in the European Union and a 10 per cent decline in the US itself. 

Indian Pharmaceutical Alliance (IPA), the industry body that represents research-based companies here, had started an initiative around three years earlier to improve quality standards among members. In 2016  six IPA members — Cadila Healthcare, Cipla, Dr Reddy's Laboratories, Lupin, Sun Pharmaceutical and Torrent Pharmaceuticals — set up a forum to address the issues of data integrity and quality culture.

The effort seems to be now bearing fruit. A study by IPA and consultancy firm McKinsey (presented recently) showed India had six per cent of FDA global inspections in 2014. This steadily rose to 14 per cent of global inspections in 2018. Of the total of 174 such inspections in India last year, only seven were classified as OAI; 91 were VAI and 76 as NAI. By contrast, in 2017, it was 22 OAI, 80 VAI and 43 NAI. “There has been a reduction in data reliability, and investigation & root cause assessment related errors," noted the study. It says gaps in manufacturing systems and laboratory controls are now a leading source of non-compliance. 

Companies are increasingly investing on improving such compliance. Rajiv Desai, executive vice-president for global quality at Lupin, says the industry is adopting more of automation; also, on investing in training and competence building of personnel, to have a better understanding on compliance issues. 

IPA’s role in bringing the industry together in this had been crucial, he adds. "There would be meetings every two to three months where we would discuss quality issues, with human resources people, plant heads, etc. There have been regular meetings with the regulatory authorities, too, and the Indian regulator (Central Drugs Standard Control Organisation) has also taken steps to ensure local inspectors are better trained,” said Desai. 

CDSCO and state food and drug control administrations have also got inspectors from the FDA and other global agencies to train Indian inspectors on compliance parameters, on how to inspect factories. H G Koshia, commissioner of the Gujarat Food and Drug Control Administration, says these efforts have been consistent.

 "Only recently, we, in collaboration with the US FDA, trained 100 inspectors on equipping drug manufacturers on audit readiness and regulatory compliance," he ststed. 

Big firms — Sun Pharma, Lupin, Cadila Healthcare, Cipla, etc —have been investing in automation and electronic data management over the years, to improve compliance. Cadila, for example, had introduced a laboratory information management system and a software that tracks deviations in manufacturing, apart from an electronic batch records system, in its new plants. 

Production data at Indian companies was earlier largely recorded manually. Now, however, with electronic data management and recording, the earlier data integrity issues with the FDA are largely a thing of the past. "The new generation of operators are more keen to adapt to new technology and this is helping automation," he added. 

A Sun Pharma spokesperson spoke similarly. “To strengthen our quality culture, we have taken multiple initiatives. These include implementing of electronic systems, enhancing global harmonised training & certification programmes and introduction of continuous process improvements, to build a sustainable culture where both the leadership and individuals have a common goal, to deliver quality products to the patient," said the spokesperson.