The pharmaceutical company in question continues operations. The India’s drug regulator has yet to act three months since the problem was flagged.
Three months after the Sri Lankan government flagged infections in at least 50 patients linked to an eye drop made in Gujarat, it is yet to receive a response from Indian drug regulators.
But Sri Lankan health officials have confirmed that they have stopped procuring the eye drop from the manufacturer, Indiana Opthalmics.
Sri Lanka had purchased the methylprednisolone eye drops in March from a Mumbai-based supplier. Sri Lankan health officials told Scroll that cataract patients in three hospitals in Colombo, Gampaha and Nuwara-eliya, who were administered the eye drop, contracted severe infections in April. At least two people have lost their vision.
Prednisolone eye drops are steroids that reduce inflammation, redness, itchiness in the eye, and are often used after cataract surgeries.
The Sri Lankan government first raised an alarm in May and wrote to the Gujarat-based manufacturer, the Mumbai-based supplier Alvita Pharma and the Indian drug regulator about it. Our regulatory authority has not received a response from the manufacturer or Indian authorities so far,” said Professor SD Jayaratne, chairman of Sri Lanka’s National Medicines Regulatory Authority, or NMRA, a government body that regulates drugs, clinical trials and medical devices in the country. In a letter sent to Alvita Pharma, Sri Lankan authorities asked the supplier to recall the eye drop.
Jayratne told Scroll that the NMRA has informed the World Health Organization about laboratory reports that revealed bacterial contamination in the eye drops.
Indiana Ophthalmic exports to over 30 countries. It continues to manufacture the eye drops despite Sri Lanka’s alert.
In the last six months, this is the third instance of ophthalmic products made by Indian companies being red-flagged for poor quality.
In January, the United States announced an import alert against Global Pharma, over contaminated eye drops that led to infections in 68 patients and four deaths. It also found multiple lapses in the manufacturing process of the Chennai-based company.
In February, the World Health Organization issued a medical alert against Galentic Pharma from Maharashtra, over the poor quality of its eye ointment. The alert forced non-profit Médecins Sans Frontières (Doctors Without Borders) and Unicef to stop procurement from Galentic.
Recently, the US Congress’s Energy and Commerce Committee conveyed its concern to the US Food and Drug Administration over the excessive dependence on Chinese and Indian drugs. The letter stated that both the countries repeatedly fail to comply with quality standards.
The complaint by Sri Lanka
Sri Lanka received the supply of methylprednisolone eye drops in March from a Mumbai-based company, Alvita Pharma, which marketed Indiana Ophthalmics products.
According to Dr DRK Herath, deputy director general (medical supply) in Sri Lanka, the first case of infection was reported on April 4.
Several patients who underwent cataract surgery at the National Eye Hospital in Colombo and the District General Hospitals in Gampaha and Nuwara-eliya complained of eye infections.
In Nuwara-eliya hospital, a special committee was appointed to look into this,” said Herath. A microbiologist drew fluid samples from the eyes of infected patients. They tested positive for gram-negative oxydase positive bacteria,” he said.
Gram-negative bacteria are pathogens that are widespread in the environment, and which can lead to vision loss if they cause severe eye infections. The gram-negative pathogen can either spread through non-sterile medical instruments used during surgery or through contaminated eye drops. Hence, during cataract surgery, doctors have to take extreme care and use sterile products.
According to protocol, Herath said, all operation theatre instruments were tested along with the eye drop after the cases increased. The eye drop lab reports came positive for bacteria,” he said.
Jayratne confirmed that the bacterial infection in patients matched with the bacterial contamination in the eye drops.
Following this, Sri Lanka’s National Medicines Regulatory Authority withdrew all methylprednisolone eye drops manufactured by Indiana Ophthalmics. After the product was withdrawn, there were no new cases of infection,” Jayratne said.
Dr ARM Thowfeek, medical director of the National Eye Hospital, told Scroll that two patients who were treated for cataract surgery in his hospital and administered the eye drop have lost their vision. In addition, several patients were referred to us from other hospitals. We treated about 50 of them,” he said.
No action in India
When contacted, Hemant Koshia, Gujarat commissioner of Food and Drug Administration, told Scroll that a team of drug inspectors had visited the Wadhwan plant of Indiana Ophthalmics in Surendranagar.
The inspection found no major deviation” in manufacturing practices, Koshia said.
The samples of their eye drops have been drawn by the CDSCO,” said Koshia, referring to India’s Central Drugs Standard Control Organisation. They are yet to communicate the lab reports.”
The Gujarat Food and Drug Administration has issued a notice to Indiana Ophthalmics after Sri Lanka raised an alert, but allowed the company to continue its manufacturing of ophthalmic products, the commissioner added.
On June 1, the Pharmaceuticals Export Promotion Council of India, or Pharmexcil, an agency under the Union Ministry of Commerce and Industry, issued a notice to Indiana Ophthalmics asking for product details, its licences and details of who it supplied the drug to.
Uday Bhaskar, secretary of Pharmexcil, said the company responded to all their queries. We have not suspended their membership,” he said. It is for the CDSCO to take action against them based on their investigation.”
On May 16, the Sri Lankan cabinet discussed the matter of eye infections and decided to conduct an inquiry and offer compensation to the affected patients.
Herath said they have established beyond doubt that the eye drops were responsible for the infection.
Koshia, however, said that there are no previous complaints about the manufacturer. Indiana Ophthalmics did not respond to an email message from Scroll.
Alvita Pharma, the supplier of the steroid, also did not respond to an email query on the quantity of eye drops recalled.
Nishigandha Pashte, drug inspector in Mumbai, said the Central Drugs Standard Control Organisation has not informed the Maharashtra FDA about the alert. Alvita did not manufacture the product here,” said Pashte. It [is] only labelled and supplied from a third party manufacturer.”
Pashte added that chances of contamination are maximum during the manufacturing stage. Once the bottle is sealed, the distributor has to only transport it,” she said.
