NHS cancels manufacturing license of pharmaceutical company

islamabad - Ministry of National Health Services in the licensing board meeting held on Friday cancelled the Drugs Manufacturing license of Everest Pharmaceuticals on its alleged involvement in manufacturing of unregistered drugs, said an official.

The statement issued said that the licensing board meeting was chaired by the Director Licensing and attended by the representatives of provincial Health Departments, Ministry of law and justice, various experts from drug manufacturing & quality control fields as members.

Statement said that Drugs Manufacturing license No.000535 of M/s of Everest Pharmaceuticals Islamabad was cancelled because the company was found involved in manufacturing of spurious and unregistered medicines.

Spokesperson NHS Sajid Shah said that Everest Pharma did not get its manufacturing license renewed after March, 2014. In this regard, Drug Regulatory Authority Pakistan wrote to the firm several times to complete the documents and codal formalities.

On failure to comply with the renewal application requirements, the firm was issued notices for show cause and personal hearing while an advertisement was also published in newspapers after non-receipt of notices by the company.

Later, a panel of inspectors visited the firm and reported that it is operating in unsatisfactory GMP conditions and is not fulfilling the requirements of the license as required under the Drugs (Licensing, Registering & Advertising) Rules, 1976.

Moreover, the manufacturing outlet was not built in accordance with the requirements of the Drugs (Licensing, Registering & Advertising) Rules, 1976. In light of the critical observations made during inspection including carrying out of manufacturing without approved qualified staff, an approved layout plan, and manufacturing without in the absence valid registration letters, the panel unanimously decided not to recommend the renewal of Drug Manufacturing License by way of formulation of the M/s Everest Pharmaceuticals, 124, Industrial Triangle, Kahuta Road, Islamabad (DML No.000535).

On the direction of Supreme Court of Pakistan, a team of DRAP officers along with FIA and NAB Teams inspected the Everest Pharmaceuticals premises. On 6th March 2018 it was reported that the firm is involved in manufacturing of unregistered, spurious and sex medicines.

Gross violations of the Good manufacturing practices were also observed. The firm was using smuggled raw material and had no import record or DRAP’s permission for import of raw materials. In clear violation of conditions of license, the firm was manufacturing drugs in unhygienic conditions to supply to the Punjab and Sindh Governments.

Meanwhile, the company owner Mohammad Usman denied the allegations and said that action against his company is a conspiracy of multinational pharmaceutical companies that are providing costly drugs to the public.  He said that his company was manufacturing low price medicine and insisted that he holds the registration documents of his company. Mohammad Usman also alleged that DRAP has become hub of corruption and that local industry is being victimized because of joint connivance of multinational companies and DRAP. 

 

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