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Islamabad, March 09, 2018 (PPI-OT): The DRAP spokesperson has informed that its Licensing Board in 258th meeting held on 08-03-2018 has cancelled the Drugs Manufacturing license No.000535 of M/s. Everest Pharmaceuticals Islamabad which was found involved in manufacturing of spurious and unregistered medicines. The 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 and quality control fields as members.
Besides this, the representatives of pharmaceutical manufacturer associations were also present as observers. The spokesperson while giving further details said that Everest Pharma did not get its drug manufacturing license renewed after March, 2014. In this regard DRAP wrote many times to the firm to complete the documents and codal formalities. The firm failed to comply with the renewal application requirements. The firm was issued notices for show cause and personal hearing. An advertisement in newspapers was also published after non-receipt of notices by the company.
Later on a panel of inspectors visited the firm and reported that the firm is operating in un-satisfactory GMP conditions and is not fulfilling the requirements of conditions of license as required under the Drugs (Licensing, Registering and Advertising) Rules, 1976. Moreover premises is not built in light of requirements under the Drugs (Licensing, Registering and Advertising) Rules, 1976.
In light of critical observations noted during inspection including but not limited to carrying out of manufacturing without approved qualified staff, without approved layout plan, manufacturing without having 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 On 6thMarch 2018and reported that 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 has no import record or DRAP’s permission for import of raw materials. The firm was manufacturing drugs in unhygienic conditions violating the conditions of license.
Ironically firm was manufacturing unregistered drugs to supply to the Punjab and Sind Governments. Keeping in view the above facts and public health at large, Licensing Board decided to cancel the manufacturing license No. 000535 of M/s. Everest Pharmaceuticals Islamabad. Moreover, an FIR has already been lodged against the owners of firm Muhammad Usman, Dr Kamran Izhaar and Noor Muhammad Mehar who were found involved in the business of spurious and unregistered medicines.
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