A deadly dose of neglect: Bitter truth behind cough syrup scare

Bottled negligence: DEG contamination exposes gaps in inspections, leaving pharma units from Gujarat to Kerala under the microscope

Travelling on the Bengaluru–Chennai highway, over 50 km from the Tamil Nadu capital, the road bisects, with a temple in the middle. Along the road on the left are a bunch of shops and showrooms. Sandwiched between a Hero MotoCorp showroom and a shop that hires out cooking utensils is a small, dingy building that’s been locked up.

 

The non-descript two-room building on the edge of Sunguvarchatram town is a manufacturing unit of Chennai-headquartered Sresan Pharmaceuticals. Over the past few days, the area has been buzzing with media personnel, investigating officers and police. It is here that the pharma company made its Coldriff cough syrup that has allegedly killed 17 children in Madhya Pradesh.

   

You don’t even have to enter the dingy building to see that the syrups were made in unsanitary conditions. The unit poor hygienic conditions outside are a telling sign of the alleged lack of inspection for more than 14 years.

 

Scattered around were several empty cans of sorbitol, a common ingredient used as a sweetener, stabiliser, and moisture-retaining agent in medicines and oral care products. On the small door grill, the state drug regulator has put up a notice saying samples tested from the unit were “adulterated and contained 48.6 per cent diethylene glycol (DEG), a toxic substance that may render the contents injurious to health.”

 

DEG can lead to kidney failure, neurological damage, and can be potentially fatal, especially in children.

 

A senior drug inspector in Chennai told Business Standard the company had been issued a show cause notice and all its products are under scrutiny. “Special focus is being given to products with DEG after the incident. They should submit a reply within a week,” the official added.

 

On the ground, Bharathi R, at the Hero MotoCorp showroom, said, “We were not even aware of what they are making at this unit. However, for the last five days, it is total chaos.” As per the notice, the firm is required to recall the drug from everyone it has been sold to, and the details of the recalled stock are to be made available to the authorities.

 

The Tamil Nadu Drugs Control Department has noted that the company failed to carry the mandatory warning that “fixed dose combination shall not be used in children below four years of age.” The department reportedly found over 364 violations at the units.

 

Other states on high alert

 

In Maharashtra, the local Food and Drug Administration (FDA) said they inspect pharma units regularly and that Coldriff is not sold in the state.

 

“The regulatory authorities need to inspect manufacturing facilities regularly. That is the only way to ensure that there is compliance with quality. Especially in the case of a chemical or excipient where both pharma and industrial grade products are available, the manufacturing units need to do quality checks and lab tests. If there are regular audits of these facilities, then this issue can be handled,” said D R Gahane, joint commissioner (drugs), Maharashtra FDA.

 

“In Maharashtra, there are 890 allopathic medicine manufacturing units. We ensure that we inspect each and every one, every year, without fail,” Gahane added. In most states, the shortage of skilled inspectors is a major challenge for regulators. In Maharashtra, there are 200 sanctioned posts for drug inspectors, but only 45 have been filled. The state public service commission has advertised for 109 drug inspector posts, which will be filled shortly.

 

The Kerala Drugs Control Department has issued a ban on the sale of all drugs manufactured by Sresan Pharmaceuticals. The state health department on Monday ordered that no medicines should be given to children under 12 without a doctor’s prescription. “Since medicines for children are prescribed according to their body weight, a medicine given to one child must not be given to another. Doing so could cause more harm than benefit,” said Veena George, the health minister.

 

The Gujarat FDA too has issued a public alert on the presence of DEG beyond permissible limits in two cough syrups - Respifresh TR and Relife.

 

Chemists too have been put on alert. The All India Organisation of Chemists and Druggists (AIOCD), which represents nearly 1 million chemists, has written to all pharma manufacturing and marketing companies asking them to comply with labelling norms for cough syrups. The letter by AIOCD president J S Shinde and general secretary Rajiv Singhal noted that despite clear Central guidelines around labelling of cough syrups indicating usage restriction for children below 4 years, there are several batches in the market where this information is either missing or not prominently displayed.

 

In Sunguvarchatram, T Kamal of Sri Bala Vinayagam Traders, which rents out utensils for parties, pointed towards the unit adjacent to his office. “They had around 10–15 employees,” he said. “The last time that I saw some action at the unit was on Ayudha Puja day.”

 

That’s the day to worship tools, machines and other instruments of work as part of Navaratri.