The country’s apex drug regulator has asked all states to share a list of cough syrup manufacturers in their jurisdiction, with the aim to conduct a special drive to audit a number of these units, sources said. The move, earlier this week, comes in the wake of at least 14 children from Madhya Pradesh dying after consuming contaminated cough syrup. “We have already started collecting data from the states. While we might not be able to check each and every unit, even conducting audits at 50 per cent of the manufacturing units will send out a strong message. We will try to inspect companies based on the historical NSQ (Not of Standard Quality) data,” said an official in the know of the matter. Recently, several glaring lapses had come to light in the case of Tamil Nadu-based Sresan Pharmaceuticals, whose syrup Coldrif was found to contain 48.6 per cent of the toxic contaminant diethylene glycol (DEG) as against the maximum permissible limit of 0.1 per cent. The gaps included the Central Drugs and Standards Control Organisation (CDSCO) not being aware of the company even existing, said sources. According to an official: “The company was first granted a manufacturing licence by the state in 2011, which was renewed in 2016. The CDSCO was not a part of this process.” The official said it was only after 2017 that a joint inspection by the state and central teams was mandated for new licences. As part of its efforts to create a more transparent system as well as a centralised database of all drug-manufacturing units in the country, the CDSCO has a portal called Online Drug License System (ONDLS). The platform can be used by the state drug regulator to provide new licences or renew them for all drug manufacturers, wholesalers, and retailers. The official said that at present, 18 states are using the portal. “If all states start providing licences through this portal, we will have a comprehensive list of all manufacturing units. There shouldn’t have been companies the central drug controller did not know about, but that was the case,” the official added. Another gap that came to the fore was that Sresan Pharmaceuticals never tested the raw materials or the finished product before releasing it to the market as mandated by the law, sources said. The official said: “It is impossible for the regulators to conduct these tests for each and every batch of medicine. The onus is on the company.” Three, the company was found to have flouted hundreds of manufacturing norms. When the Tamil Nadu drug controller inspected its premises on October 1 and 2 after receiving information from MP, they found 39 critical deficiencies and 364 violations. “What this essentially means is that the company had a problem in every manufacturing process,” the official said. The state drug controller issued a show-cause notice and a stop-production order. The Centre, after its inspection a day later on October 3, recommended that its licence be cancelled. Two other syrups — among the 19 drugs consumed by the children — were also found to contain higher than permissible levels of DEG. Testing by state drug regulators revealed that one of them, Gujarat-based Rednex Pharmaceutical’s Respifresh, contained 1.3 per cent DEG. Both companies have been given stop-production order by the Gujarat controller. The World Health Organization (WHO) has said that it is closely monitoring the situation and will support national authorities in investigating the incident. The WHO has also asked whether any of the three cough syrups were being exported, to which the drug regulator said that these were marketed only domestically. All syrups meant for export have to be tested by government laboratories, but there is no such process for syrups being marketed domestically.
