Delhi plans to make pre-export testing of cough syrups mandatory, according to Indian news channel News18.
The Ministry of Health and Family Welfare is reportedly drawing up legislation to implement a system of checks on syrups at government laboratories before final dispatch.
According to the news outlet, the ministry received a proposal sent by drug regulatory agency the Central Drugs Standard Control Organisation (CDSCO) in the first week of May.
The move comes in the wake of allegations from Uzbekistan and Gambia last year of child deaths after consuming cough syrups manufactured in India.
In December, Uzbekistan alleged that 18 children died after consuming Dok 1 Max cough syrup made by Marion Biotech. The Indian government scrapped Marion Biotech's license in March.
Likewise, Gambia alleged that 66 children died after consuming cough syrups from another Indian firm, Maiden Pharmaceutical.
Two Oceania's island countries, Micronesia and Marshall Islands, have also alleged that made-in-India cough syrups were found to be contaminated with toxic chemicals.
According to experts, cough syrups generally require solvents like propylene glycol, glycerine, and sorbitol because of their insolubility. To fix the issue, companies use adulterants like diethylene glycol (DEG) and ethylene glycol (EG) – the industrial version of glycerine – that is toxic to the kidney and can also lead to fatality, especially among children.
The Indian drug regulator also told the WHO in its investigative report that both Maiden and Marion used propylene glycol in their cough syrups.
Currently, India's pharmaceutical business is estimated to be worth $50 billion. However, regulations regarding export quality remain loose and chaotic, while smaller nations find it difficult to test imported medicine.
Certificate of Analysis
As per the report, under the proposed legislation exporters would have to produce a certificate of analysis that will be given by the government laboratories after they approve the batch.
"These samples can be tested at Indian Pharmacopoeia Commission and six CDSCO network labs based in Chandigarh, Kolkata, Chennai, Hyderabad, Mumbai, and Guwahati. Apart from these labs, these samples can also be tested at NABL-accredited drug testing labs of the state government, as per the proposal," a senior official told the news outlet.
The officials also said that authorities were looking to repair the damage done by the incidents in Gambia and Uzbekistan that raised doubt about India's pharmaceuticals.