Pharmexcil probes drug smuggling case

New Delhi: The government agency responsible for promoting pharmaceutical exports, Pharmexcil, has sought an explanation from Andhra Pradesh-based Safe Formulations Ltd in a case of alleged smuggling of the banned psychotropic drug Tramadol after customs officials arrested a director at the pharma company.

The drug shipment was caught by customs officials in Andhra Pradesh en route to South Sudan, from where it was to be smuggled to other countries. The pharma company had supplied the drugs to two firms—First Wealth Solutions and Irishealth Global Wellness Pvt Ltd—which are allegedly involved in smuggling the drugs.

Tramadol is a psychotropic substance and painkiller extensively abused the world over and it was banned in India in April 2018. Pharmexcil said the episode has brought a bad name to the Indian pharma industry.

Safe Formulations Pvt Ltd registered with Pharmexcil in 2008 as a small-scale manufacturer. Pharmexcil has asked the company to furnish the details of licensees, procurers, manufacturing license copies and product permissions of the drug by 27 April, failing which its registration will be suspended, said Pharmexcil director general Uday Bhasker.

“It has come to our notice that the Central Intelligence Unit of the Mumbai Customs department, based on specific intelligence, intercepted a consignment on 27 February, and seized around 1 million Tramadol tablets worth approximately 21 crore destined to a pharmacy firm in Juba, South Sudan. The shipment was examined at the air cargo complex in Sahar and during further investigation, it was revealed that Safe Formulations Pvt Ltd in Guntur, Andhra Pradesh, had provided the said goods to—First Wealth Solutions.

Customs officials under the Narcotics Drugs and Psychotropic Substances (NDPS) Act have arrested Sangala Sridhar Reddy, director of Safe Formulations Pvt Ltd, a medicine manufacturing company based in Andhra Pradesh for allegedly supplying Tramadol to two other firms which would allegedly smuggle them further to several countries including Sudan, via air cargo,” said Bhaskar in a communication to Govinda Reddy Balineni, director at Safe Formulations.

Queries sent to Safe Formulations did not elicit any response.

The probe has also revealed that Safe Formulations had provided 33.1 million strips or 15,745 kg tablets to First Wealth Solutions in the past. It is not clear whether they were all Tramadol. The consignment was allegedly wrongly declared as Tamol-X-225, a calcium carbonate tablet.

The letter said the incident is also likely to have an impact on the trust of international agencies on Indian pharma exports.

Contaminated cough syrup made by an Indian company has been found in the Marshall Islands and Micronesia, the World Health Organization (WHO) said on Tuesday, after child deaths linked to other syrups in some countries last year.

The WHO statement did not say whether any children in the Marshall Islands or Micronesia had fallen sick.

But it said samples from a batch of imported cough syrup, with the product name Guaifenesin syrup TG syrup, were contaminated with unacceptable amounts of diethylene glycol and ethylene glycol, which can prove fatal. The contamination was identified by Australia’s regulator, the Therapeutic Goods Administration (TGA).

The stated manufacturer of the medicines in the latest alert was QP Pharmachem Ltd, based in Punjab and the marketer of the product was Trillium Pharma, based in Haryana, the WHO said. Neither QP Pharmachem nor Trillium have provided guarantees to WHO on the safety and quality of these products, the agency said in the statement.

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