Islamabad, November 29, 2015 (PPI-OT):Drug Regulatory Authority of Pakistan and Umair Majeed Drug Controller Mr. Umair Majeed inspector Sahiwal jointly raided the distributor of Global Pharmaceuticals and recovered 333 packs of unregistered Tamsol-D tablets. Each film coated contains Tamsin hydrochloride 0.4mg as modified release and Dutasteride. The registration was granted to the firm on 11th September 2012. Later on it was identified that above formulation does not exist in tablet dosage form internationally or locally.
However, it is available in capsule dosage form during 29th meeting of Drug Registration Board on 12th September 2013, it was decided that to ask the manufacturer to appear before Registration Board for presentation of the opinion regarding efficacy of the drug formulation.
The Board further ordered that till final decision, the registration of Tamsol-D tablets will remain suspended under Section 7 (11) (ad) of Drugs Act 1976. Drug Regulatory Authority of Pakistan is committed to protect and safeguard the consumers of medicines DRAP will not spare any Licensing unit, distributor or retail pharmacy who is involved in manufacture, distribute or sale of unregistered, spurious, counterfeit, misbranded, overpricing, substandard and out of specifications drugs, medicated cosmetics, Herbal and Homeopathic medicines, medicated devices, milk and baby products and blood and blood products.
For more information, contact:
Haji Ahmed Malik
Principal Information Officer
Press Information Department (PID)
Tel: +92-51-9252323 and +92-51-9252324
Fax: +92-51-9252325 and +92-51-9252326