Mumbai: The US drug regulator has found seven breaches of manufacturing standards at Sun Pharmaceutical Industries Ltd’s formulations plant in Mohali, Punjab, following a recent inspection.
The Mohali facility, which belonged to Ranbaxy Laboratories Ltd, has been under an import alert sounded by the US Food and Drug Administration (FDA) in 2013, two years before Sun Pharma completed its $4 billion acquisition of Ranbaxy.
Ranbaxy’s units at Dewas (Madhya Pradesh), Paonta Sahib (Himachal Pradesh) and Toansa (Punjab) are also under the FDA import alert, which bars drugs manufactured in these plants from being sold in the US market.
Sun Pharma is struggling to resolve compliance issues at Ranbaxy’s plants as well as its own manufacturing facilities at Halol and Karkhadi in Gujarat. Regulatory issues, particularly at the Halol unit, have dented the company’s sales in the US. In 2015-16, US sales were $2.07 billion, down 8% from the previous year.
The US drug regulator inspected the Mohali plant between 7 November and 16 November and issued the so-called Form 483, citing four deviations from norms in the laboratory system, two in the quality system and one in the production system, according to a copy of the Form 483 accessed by Mint.
A Form 483 is issued to a company’s management at the conclusion of an inspection when investigators observe any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic Act and related Acts.
Sun Pharma declined to comment on the issue.
Analysts said that one of the observations on the laboratory system on the company’s alleged failure to thoroughly review the reasons for an out-of-specifications batch of drugs was critical in nature, but the other observations were not as severe.
The other observations in the laboratory system were lack of appropriate controls over computer systems, incomplete record data, and lack of examination and testing of samples to assure that in-process materials conform to specifications.
The FDA observed that the quality control unit lacked the authority to review production records and to reject all procedures that have an impact on the quality of products.
On the production system, the company failed to present written procedures for production and process controls designed to assure that the drugs have the identity, strength, quality and purity they claim.
“The first observation in the laboratory system is a little out of line, but most of the issues are fixable. However, getting the plant back to compliance will be a lengthy process for the company,” said an analyst, who did not wish to be named.
Another analyst said issues at the Mohali unit are unlikely to get resolved in the near to medium term, but there will not be any financial impact on the company as it does not supply any products to the US market from that facility.