Doctors' safety alert led to Sun Pharma eye drop recall

Mumbai: Sun Pharma's decision to recall 11 eyecare products in July came after an influential body of eye specialists issued a patient safety alert the previous month about bacterial contamination of certain batches of its Predmet eyedrop, documents suggest.

The All India Ophthalmological Society (AIOS), a body of nearly 27,000 eye specialists, on June 19 informed its members that multiple ophthalmic institutions found contaminations consistent with pseudomonas species in some batches of the prescription medicine.

Severe Infections


Sun Pharma later withdrew the medicine used for treating conditions such as eye redness and itching caused by allergies to severe infections. It ordered a wider recall on July 17, covering 11 other eyecare products including Depopred2ML, Brinolar, Brizotim, Lotepred and Nepalact as a precautionary step.

The company did not disclose any specific reason that prompted it to take the step, stating only that the decision was made as a matter of "abundant precaution". The AIOS note, which ET has seen, stressed that patient safety was paramount given the potential risk of serious ocular infection associated with contaminated ophthalmic preparations. "AIOS recommends a precautionary approach until further information becomes available," it said.

The AIOS recommended its members to avoid using the quarantined batches until investigations were completed. It also advised doctors for heightened vigilance for ocular infections, particularly keratitis (inflammation of the cornea), postoperative infections, endophthalmitis (internal infection of the eye), or unexplained ocular inflammation in patients who may have been exposed to the product. "Promptly investigate suspected cases with appropriate workup and institute treatment as clinically indicated," it added.

The adverse events committee of the AIOS said similar microbiological characteristics were observed across multiple affected samples. "These findings raise concern regarding a potential common-source contamination and warrant immediate precautionary measures while investigations continue," it said.

AIOS did not respond to ET's queries. The severity of infection by pseudomonas, a family of bacteria found widely in nature, can range from mild and self-limiting infections to causing serious ocular damage to patients, said experts.

An acclaimed ophthalmic surgeon, however, told ET that to date he has not found any cases of endophthalmitis caused by the use of this product. On August 1, in a letter seen by ET, Sun Pharma alerted medical experts that roughly 26 eyecare products sold in India were "not manufactured from the affected facility".

The company did not disclose the affected manufacturing site or share details of the issues that resulted in the withdrawals. The note added: "These products are manufactured either at qualified alternative Sun Pharma manufacturing sites or at external manufacturing facilities that operate independently of the site where the issue was identified."

'Not Affected List'

Among the products listed by Sun Pharma on the "not affected list" were Cequa, Careprost LS, Gatilox DM, Timolet OD, and Cafta. In response to ET's queries, Sun Pharma said in a statement: "We have initiated a proactive voluntary withdrawal of some ophthalmic products as a matter of abundant precaution. Product quality and patient safety are important to us, and remedial measures have been put in place."

An industry expert said if there is credible evidence that a manufacturing facility has been contaminated, the response should be clear, transparent and decisive.

According to data from market intelligence firm PharmaTrac, India's ophthalmic drugs market is worth ₹4,721 crore, growing at 6% annually. Some of the top players are Allergan, Micro, Ajanta, Entod, Intas and Alembic.