Six Indian drug makers have been pulled up for quality lapses by Sri Lanka’s ministry of health.
The Lankan ministry was concerned at the quality of some batches of injections supplied by them. It had then restrained three of the six companies — Belco Pharma, based in Delhi, and Kilitch Drugs and Umedica Laboratories, both based in Mumbai — from supplying medicine for two years.
It was in November that U A Mendis, director-general of health services, Sri Lanka, stated stated that some batches of injections manufactured by these companies had failed quality tests. The other three companies — Vin Bioproducts, Baxter India and Mercury Laboratories —- were asked to withdraw the batches of vials/bottles that were of questionable quality.
“The order has been reversed and all six of us are now supplying medicines to Sri Lanka,”said P K Gupta, managing director, Belco Pharma. “The Indian firms were able to convince the Sri Lankan government of the quality of the products within weeks,” he added.
| SRI LANKA’S COMPLAINTS | |
| Vins Bioproducts Ltd: | Discoloured and clumped vials of anti-snake venom serum |
| Kilitch Drugs (India) Ltd: | Cefuroxime injection failed quality test |
| Umedica Laboratories Pvt Ltd: | Hydroconisone injection failed quality test |
| Baxter India: | Bottles failed quality specification |
| Belco Pharma: | Pethidine injection failed test |
| Mercury Laboratories Ltd: | Promethazine injection failed test |
The companies had also sought help from the Indian Pharmaceutical Export Promotion Council (Pharmexcil) to take up the matter with the Sri Lankan authorities, Gupta said.
India exports Rs 350 crore of medicines to Sri Lanka annually, 24th on the value list. Indian drug export companies are coming under the regulatory scanner in several countries, as regulators across the world are stepping up vigil over supply of sub-standard medicines in their countries. For instance, two of Ranbaxy’s Indian drug manufacturing sites face export bans in US due to quality concerns. Some years earlier, Nigeria had blacklisted a dozen Indian drug exporters for alleged supply of sub-standard medicine.
In all these cases, the companies, individually or through Pharmexcil, have argued their case with the drug regulators.
