Indian pharma companies continue to be at the receiving end of tough quality scrutiny by drug regulators abroad, the latest being Jubilant Pharmaceuticals NV, the Belgium subsidiary of the Rs 3,500-crore Jubilant Organosys.

Jubilant Pharmaceuticals NV has been asked by UK Medicines & Health Regulatory Authority (MHRA), the largest drug watchdog in Europe, to recall various batches of its product, amlodipine besilate, from the UK market following ?serious good manufacturing practices (GMP) deficiencies? found during an inspection of its contract manufacturer, Mumbai-based MJ Bio Pharma.

The products are distributed through Wockhardt?s UK arm. Amlodipine besilate is the copycat version of Pfizer?s $4.8-billion hypertension drug Norvasc, which went off-patent in 2007, opening the market to generic competition.

The alert, issued on June 29, asked the company to recall the drugs within 48 hours from the shelves across the UK.

The market size the recalled products could not be immediately ascertained, but Jubilant has a growing global presence, and has garnered Rs 2,177 crore revenues from international operations in FY09. The company sells mostly in the US, followed by Europe. In Europe, it had revenues of Rs 108 crore in the fourth quarter of FY09.

The company may still not be hit by a loss of reputation in the UK market, since the size of the recall is relatively small. However, the growing number of Indian companies coming under the regulatory scanner is indeed a cause of concern for all Indian generic manufacturers, experts feel.

Responding to queries from FE, a Jubilant Organosys spokesperson said, ?Jubilant Pharmaceuticals NV holds a few market authorisations using MJ Bio Pharma (MJBP), which failed EU-GMP audit by UKMHRA in June 2009, and consequently, Jubilant has recalled its products: Amlodipine 5mg and 10 mg tablets from the market. However, this recall pertains to the supplies made from MJBP in 2008. The value of the products recalled is insignificant to the overall turnover of Jubilant. During 2009, the supplies of this product have been made to all customers through Jubilant?s UK MHRA approved facility at Roorkee in India.?

Jubilant shares were down 1.12% on the Bombay Stock Exchange on Wednesday at Rs 163.50. The alert comes under the class 2 drug alert. Though not as severe as class 1 recall, class 2 recalls are for products that might cause a temporary health problem, or pose slight threat of a serious nature.

Last week, 33 drugs of Caraco Pharma, the US arm of Sun Pharma, were seized from its US facility for inferior quality. Daiichi Sankyo-owned Ranbaxy Laboratories, India?s largest drug-maker, had to face the FDA ire, when 30 of its products from two Indian facilities were banned in the US.

In April, Wockhardt UK has been issued a class 4 alert for its blood-thinning drug heparin sodium products by the MHRA. The products had been found with a very low level content of the active raw material used in it. However, due to a potential out-of-stock situation, these products were not being recalled. During November 2007, Mumbai-based FDC Ltd had recalled five ophthalmic drugs from the UK market following a MHRA instruction.

Hitesh Gajaria, head-pharmaceuticals & executive director, KPMG, said: ?Following patent expiries, more generic players throng the developed markets with their copycat versions. The regulators in each country, especially the largest markets such as the US and UK, who are concerned about the protection of their citizens, take a tough stance against violators.? However, it would not be right to conclude that Indian companies are being targeted by the regulators often, he added.

Class I recalls are for dangerous products that predictably could cause serious health problems or death, while class III recalls are for products that are unlikely to cause any adverse health reaction, but that violate FDA labelling or manufacturing regulations.