Indian health authorities closely monitoring contamination reports on Indian medicine in SL

In reference to the incident where several patients in Sri Lanka were found with minor eye complications after the use of a medicine manufactured by one of the renowned Ophthalmic products manufacturing companies in India, the Indian health authorities are closely monitoring the incident and coordinating with the relevant company.

What really happened

According to Sri Lankan health authorities, complications had caused due to the use of 'Prednisolone', an eye drop following the cataract surgery. The Health Ministry of Sri Lanka also decided to withdraw the batch following the detection of patients with complications. In this context, concerns were raised as to what contaminated the medicine resulting in causing complications to several patients.

The investigations carried out by local authorities, has found that a bacterium named 'micro-bug Burkholderia cepacia' is responsible for causing the infections among the patients. However, the Indian health authorities are currently examining the incident in coordination with the relevant company that manufactured the medicine in question and are yet to come out with an official statement.

In this sense, what it is intriguing is that whether the medicine was contaminated during the production, transportation, storage or opening of the medicine. Hence, a comprehensive analysis should be done in order to ascertain the actual cause.

Having said that, Sri Lanka Health Director General Dr Asela Gunawardena has stated that the bacterium which was found in the eye drop, had not been detected in the pre-shipment samples sent by the Indian supplier.

Nevertheless, he had told the local media that "It is not practical to test every sample and thus the clearance was given for the order. Unfortunately, the bacterium was found in several samples, which caused complications,"

He proceeded to note that the Indian Company had held a discussion with officials of the State Pharmaceuticals Corporation (SPC) where the company representatives agreed to test every batch, at whichever laboratory in Sri Lanka.

The victims demand compensation 

The patients who developed complications have demanded financial compensation for the damage caused to their eyes and possible threats to their lives, local media reported.

One of the victims, speaking with a local newspaper said “The complications started to present after about 14 days. It’s as if I have a spider web over my operated eye. My vision gradually started to weaken. Troubled by this, I went to the hospital to seek advice and was told to admit myself at the hospital again,” 

“We need compensation for what happened to us. Our lives are now in peril. We have nothing to do with it. The fault is with the government. Therefore, we demand financial compensation,” he added.  
In response to this, the Sri Lankan Health Minister Keheliya Rambukwella has issued directive to the Ministry Secretary to inform this regard to the Indian Company named Indiana Ophthalmics and brief the matter to the supplier as well.

Expressing his remarks on the matter, the Health Minister told media that quality failures could occur at times and adding there had been similar incidents of this nature globally as well.

In this context, Sri Lanka is awaiting a response from the Indian Company. 

Meanwhile, it should be mentioned that Sri Lanka is one of India’s major development partners and this partnership has been an important pillar of bilateral ties between the two countries. Against this backdrop, India has been the key exporter of medicines to Sri Lanka with highest quality. This is evident with the number of medicines that Sri Lanka received during the crisis period under the Indian Credit Line. As such, Sri Lanka is always grateful to the generous support extended to Sri Lanka over the years.

About the manufacturer 

Indiana Ophthalmics LLP was started in 1981 with focus on speciality manufacturing of Ophthalmic products (Eye Drops and Eye Ointments). Indiana Ophthalmics LLP is growing very rapidly with strong presence of the products in the domestic market with almost entire India and across more than 30 countries in the world. Currently the company offers more than 135 formulations in Ophthalmic.

Indiana Ophthalmics LLP has been approved by WHO-GMP since 2007 with strong market presence in countries like Chile, Turkmenistan, Kazakhstan, Nigeria, Ghana, etc. In addition, the company is focused on marketing the entire range of our products in the entire Africa, Latin America, CIS countries and South-east Asia.

About the supplier 

Alvita Pharma is a young company engaged in the development, registration, manufacture and marketing of Pharmaceutical products to countries in Asia, Eastern Europe and Africa. Its capabilities include integrated product development including pre-formulation studies, complete formulation development, Stability studies, Technology transfers, Dossier development and Product registration.

According to the Sri Lanka Health Minister, the supplier has been supplying medicines for the last seven years to Sri Lanka and is registered under the National Medicines Regulatory Authority (NMRA) and the European Union.