38 drugs made in Haryana failed quality tests since 2019

Bhartesh Singh Thakur

Chandigarh, October 10

As poor supervision by Haryana’s Food and Drug Administration (FDA) has brought Sonepat-based Maiden Pharmaceuticals under the scanner for 66 children’s deaths in The Gambia, the Central Drugs Standard Control Organisation (CDSCO)’s data shows that 38 drugs manufactured in the state failed quality tests across the country since 2019.

Repeated failures

Most of the firms whose products were declared not of standard quality are located in Faridabad, Sonepat, Karnal, Hisar, Ambala, and Yamunanagar. There are instances where the same firm’s drugs are failing the tests again and again

The CDSCO issues monthly alerts on drugs failing quality tests on its website. As per the data, six drugs manufactured in Haryana failed quality tests in 2019, which rose to 10 in 2020. In 2021, nine drugs failed tests across the country.

From January to August 2022, 13 drugs produced in the state were declared not of standard quality. In February 2022, telmisartan tablets of Faridabad-based Nestor Pharmaceuticals failed in Jharkhand, ranitidine tablets of Faridabad-based Hindustan Antibiotics failed in test at a central laboratory in Guwahati, and intravenous infusion set of Sonepat-based Lars Medicare Private Limited failed in Kerala.

In March 2022, calcium and Vitamin D tablets and doxycycline capsules of Faridabad-based Hindustan Antibiotics failed in a central lab in Kolkata, and intravenous infusion set of Sonepat-based Lars Medicare Private Limited failed in Kerala. In April and May, telmisartan tablets of Faridabad-based Nestor Pharmaceuticals failed in Jharkhand.

In June, ibuprofen tablets of Hindustan Antibiotics failed quality tests in a central lab of Kolkata, paracetamol tablets of Faridabad-based alco formulation failed in Assam and iron and folic acid tablets of Nestor Pharmaceuticals failed in the tests at central lab of Chandigarh.

Similarly in July, telmisartan tablets of Nestor Pharmaceuticals failed in Jharkhand, and in August, paracetamol tablets of alco formulation failed in Assam.

Most of the firms whose products were declared not of standard quality are located in Faridabad, Sonepat, Karnal, Hisar, Ambala, and Yamunanagar. There are instances where the same firm’s drugs are failing the tests again and again. Most of these drugs have failed on dissolution, assay, acid value, pH, uniformity of content, particle size, and particulate matter tests.

As per Section 52 of Drugs and Cosmetic Rules, 1945, drug inspectors have to inspect all premises licensed for the manufacture of drugs within the area allotted to them once in a year to satisfy themselves that the conditions of the licence and provisions of the Drugs and Cosmetic Act and the Rules were being observed. They have to see the means employed for standardising and testing the drugs, the methods, and place of storage, the technical qualifications of the staff employed and all details of location, construction and administration of the establishment likely to affect the potency or purity of the product.

They have to send a report regarding the inspection to the controlling authority too. In Haryana there are only 19 field officers against 56, implying two-thirds vacancies, said officials in the Food and Drug Administration, Haryana. The shortage is impacting the supervision as Section 52 is hardly complied with.

“When a drug manufactured in Haryana fails the quality test in any other state, the regulatory authority concerned informs the FDA, Haryana, which has to take steps for stopping the production of that particular drug,” said GL Singhal, former state drug controller, Haryana.