Drug makers dial foreign regulators on quality issues

Domestic pharmaceutical companies have decided to step up collaboration with foreign drug regulators, with compliance issues at factories here continuing to impact business.

Indian Pharmaceutical Alliance (IPA), the industry body representing research-based companies, has invited regulators from America, Britain and the European Union to address supervisors and mid-level managers at members’ factories in Ahmedabad, Chandigarh, Goa and Hyderabad, on good manufacturing practices and quality culture. The workshops will be in November.

"Quality issues are on ongoing challenge for the Indian pharmaceutical industry. Of the 42 warning letters issued by the US Food and Drug Administration (FDA) last year, nine went to Indian facilities,” Mary Lou Valdez, the US regulator’s associate commissioner for international programmes, said in March.

Recently, the French and German regulators raised concerns regarding deficiencies in good manufacturing practices at plants of Biocon and Dr Reddy's Laboratories (DRL).

IPA says it is bringing industry and regulators together to address these concerns. The regulatory action has delayed product approvals and hit earnings.

"Companies have invested in automation and electronic data management. But, data recording is still partly manual and partly electronic. Data has to be recorded correctly and on time. We are stressing on quality culture and behaviour, so that there are no data integrity issues," said D G Shah, secretary general of IPA.

Last year six of the body’s members — Cadila Healthcare, Cipla, DRL, Lupin, Sun Pharmaceutical and Torrent Pharmaceuticals — set up a forum to address the issues of data integrity and quality culture. Data reliability guidelines have been framed and are being implemented in 12 manufacturing sites of these companies.

Another reason for the collaboration is greater foreign regulatory oversight on Indian sites. The number of FDA inspections at factories in India tripled between 2010 and 2015. From 2010 till June 2016, inspections were done 840 times in India, more than in any other foreign country. That is partly because India is the second largest drug exporter to the US by volume and fifth largest by value. The increase in audits follows introduction of norms in 2012 to expedite drug approvals and end disparity between domestic and foreign inspections.

"The proportion of inspections with adverse observations has been going up, with many of these being escalated into warning letters as the FDA tightens regulatory norms, under a stricter regime. This has resulted in significant opportunity losses in terms of earnings, as a result of delays in launches from the affected facilities, as well as the incremental costs involved in resolving these," say Anmol Ganjoo and Agraj Shah of JM Financial in a recent report.

Resolution at key facilities of Sun Pharma (Halol unit), DRL (Duvvada, Srikakulam plants) and IPCA (Ratlam) has been unsuccessful so far. Cadila and Lupin were able to complete remediation of their facilities at Moraiya and Goa, respectively.

During the year, there were several new facilities where good manufacturing practice deviations were detected by the FDA—Bachupally (Dr Reddy’s), Dadra (Sun Pharma), Visakhapatnam (Divi’s Labs) and Goa (Indoco Remedies).

"The ongoing challenges with respect to the regulatory compliance of key facilities are resulting in delay in approvals/launches of products, critical to maintaining growth momentum in the US," Ganjoo and Shah said.