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Posted at: Apr 17, 2018, 12:28 AM; last updated: Apr 17, 2018, 12:28 AM (IST)

Cell to check manufacture of substandard drugs

Tightening noose on pharma firms

  • State Drugs Controller Navneet Marwaha said the cell had been constituted to tighten noose on the pharmaceutical companies whose drug samples were regularly being declared sub standard by the CDSCO.
  • The cell will inspect these units and its recommendations will have to be abided by the erring firms within a time-bound manner failing will strict action will be initiated against them.

Ambika Sharma

Tribune News Service

Solan, April 16

In a bid to strengthen regulatory mechanism over pharmaceutical manufacturers in the state, an intelligence cell comprising officials from the state and central drug authorities has been constituted by the Drug Control Administration.

The cell will be headed by Assistant Drug Controller Garima Sharma and will have one Drug Inspector (DI) from the state and two others from the Central Drug Standard Control Organisation (CDSCO). The action follows a review of the existing regulatory mechanism where the need to strengthen the regulation through a joint inspection has been mooted.

State Drugs Controller Navneet Marwaha said the cell had been constituted to tighten noose on the pharmaceutical companies whose drug samples were regularly being declared sub standard by the CDSCO.

The cell will inspect these units and its recommendations will have to be abided by the erring firms within a time-bound manner failing will strict action will be initiated against them. The working of the cell will be reviewed after every 10 days for effective regulation over erring manufacturing units.

Since cases involving sub-standard drugs require an in-depth investigation to pinpoint the cause and a dedicated team of officials to deal with such cases was the need of the hour.

Whenever such cases come to light, the erring unit is issued show cause notice followed by inspections to detect its cause and laxities found are supposed to be removed within a time-bound manner. In case a firm fails to check the laxities it can also face suspension of its licence, Marwaha said. Licence of a Barog-based unit was suspended recently as it failed to rectify the objections.

As many as 14 such firms have been inspected in the last two months after their drug samples were repeatedly found sub-standard by the CDSCO.

He added they were endeavouring to ensure manufacture of safe, quality and efficacious drugs and promotion of four DIs to Assistant Drug Controllers has further helped them strengthen the regulatory mechanism.

There were more than 700 drug manufacturing units in the state with a majority of them being based in the Baddi-Barotiwala-Nalagarh and Kala Amb and Paonta Sahib areas. Despite enhancement of the strength of the Drug Inspectors in the recent years, their strength was still inadequate to ensure effective regulation over the manufacturing units.

The state had just 16 DIs as against the sanctioned strength of 44.

In the BBN area, which was also known as the pharmaceutical hub of Asia, as against the requirement of 12 DIs there were barely 3 DIs to regulate the 400 units. Similarly, in the Kala Amb and Paonta Sahib area only two DIs were catering to the nearly 150 units as well as retail and wholesale shops.

Provision of adequate DIs was the urgent need of the hour as the state was short of 28 DIs. Though appointment of 12 DIs was in the offing it remains to be seen how soon these posts are filled.

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