The Union Government, on 22 May, notified an order stating that made-in-India cough syrups will have to go through mandatory quality checks in government-run labs before they are cleared for export. This direction will come into effect starting 1 June.
While any move to strengthen drug regulations in India are welcomed by experts in the field, this particular order throws up two important questions:
Why only cough syrups?
Why are these tests being made mandatory for only units meant for export?
The Image Problem of India-Made Cough Syrups
To understand the context of this order, let's rewind a bit. Since the Gambia incident in 2022, where at least 60 children died in the country, due to acute kidney injury, after they had consumed cough syrups manufactured by an Indian drugmaker, cough syrups made in India came under the radar of global health authorities.
Later in December 2022, Uzbekistan claimed that at least 18 children in the country had died after allegedly consuming cough syrup manufactured in India. The laboratory tests of a batch of syrups found "the presence of ethylene glycol", a toxic substance.
Although the stance of Indian authorities, in both incidents, has been to deny any links to these cough syrups, the World Health Organization (WHO) has, on multiple occasions, issues medical product alerts on India-made cough syrups.
Speaking to FIT, Malini Aisola, co-convener of the All India Drug Action Network (AIDAN), suggests that this seems like a move to reassure the global community about the quality of cough syrups being exported, in a bid to mitigate the 'bad publicity' that the Centre is facing because of these incidents.
The notification issued by the Director General of Foreign Trade introduces the requirement for a company to produce a Certificate of Analysis (COA) issued by an approved governmental lab for clearance of each export consignment.
This is an additional check that is being put in place for all cough syrups that will be leaving the country.
"This was proposed by the DCGI because they have acknowledged that there have been these incidents recently that are bringing disrepute to India and there was a need for some sort of a governmental intervention in this area."Malini Aisola, co-convener of the All India Drug Action Network (AIDAN)
This order, incidentally, comes on the heel of a report by Bloomberg on how a panel of international experts has found strong links between contaminated cough syrups from India and the deaths of more than 60 children in the Gambia.
‘Good Move, but Is It Enough?'
While the move in itself is a step in the right direction, the experts who spoke to FIT say the scope of it is too limited.
For one, the order only applies to cough syrups, and curiously doesn't cover all pharmaceuticals, "even though the recent incidents that took place in the Gambia and Uzbekistan were because of various syrup-based and paediatric formulations," says Aisola.
"This in spite of the fact that the majority of the children's deaths in the Gambia were due to oral medication containing promethazine (i.e., not a cough syrup)."Malini Aisola, co-convener of the All India Drug Action Network (AIDAN)
‘Don’t Domestic Consumers Matter?'
Speaking to FIT, Shreya Shrivastava, Senior Resident Fellow at the Vidhi Centre for Legal Policy, points out that the order was issued by the Ministry of Commerce and Industry, and the Director General of Foreign Trade, and not the Ministry of Health.
Considering the requirement applies only to cough syrups meant for export, "this is very much within the jurisdiction of the Ministry of Commerce to do so," she adds.
However, the question that then arises is, why?
"This (order) is off because it is clearly creating a distinction between cough syrups which are meant for export, and the ones that are sold in India."Shreya Shrivastava, Senior Resident Fellow at the Vidhi Centre for Legal Policy
Shrivastava points out that there have been multiple instances of quality lapses when it comes to generic medicines, especially cough syrups, being sold in India as well.
"How can you ignore the fact that these same manufacturers are marketing the same products in India as well?" she says.
"If they really wanted to ensure the quality of drugs, why are they not holistically applying these provisions that are being manufactured in India?"Shreya Shrivastava
Adding to this, Aisola says, "While not a bad move, it is obviously superficial and doesn't get to the root of weak regulatory oversight in the country. There are more serious steps that can be taken."
"The sustainable solutions," she adds, "obviously lie in 'cleaning the house' and strengthening enforcement."
Dr N Devadasan, public health policy expert and co-founder and director of Institute of Public Health, Bengaluru says, "There are already certain provisions in place like the Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP) to ensure checks on the manufacturing of generic medicines, however, they are often not carried out properly."
"In reality, they are not carried out effectively because one, we do not have enough human resources, and we do not have enough independent laboratories to check on them."Dr N Devadasan
"Even when you have provisions in paper, they need to be monitored, and action needs to be taken when violations are found," says Aisola.
FIT has reached out to the Ministry of Health and the Ministry of commerce. The copy will be updated based on their response.