Federal govt puts sanitizer manufacturing under DRAP’s control

LAHORE: In a surprise move the federal government has put hand sanitizer manufacturing under the control of Drug Regulatory Authority of Pakistan (DRAP) and allowing controlling it as regulated item like pharmaceutical products, instead of Pakistan Standards and Quality Control Authority (PSQCA) which controlled all such personal care products and acknowledged globally.

According to a notification F.No.4-2/2017-DD (H&OTC) on April 6, 2020 issued by Ministry of National Health Service, Regulations & Coordination Drug Regulatory Authority of Pakistan stated that considering the public health urgency and the dire need of availability of quality hand sanitizers during Covid-19 pandemic decided that the manufactures having a valid Drug Manufacturing Licence (DML) or valid Enlistment Certificate (Form-6) with topical or external preparation section may prepare hand sanitizers with the WHO recommended formulation only on campaign basis for a period of three months with the provisional permission of the health department and OTC division.

According to the WHO recommended formulation, a hand sanitizer contains ‘alcohol’ (ethanol) 80 percent volume in an aqueous solution denatured or Isopropyl Alcohol 75 percent volume in an aqueous solution, glycerol 1.45 percent volume and hydrogen peroxide 0.125 percent volume. The notification further ordered that the applicant may apply to the health department and OTC division along with fee of Rs5000 for a provisional permission for campaign manufacturing which will expire on July 2, 2020.

Interestingly, before issuance of DRAP notification, the PSQCA conducted quality tests of the hand sanitizers across the country on the instruction of Science and Technology Minister Fawad Chaudhry and collected 60 samples of different hand sanitizers being sold in the markets.

PSQCA Director General Aleem Memon while talking to The News said the quality standards tests were made in accordance with the WHO guidelines and report was submitted to the minister. “We are preparing the quality standards for the hand sanitizer and formally request the government through Cabinet to include it under PSQCA domain through mandatory inclusion,” he said, adding that the government gave the hand sanitizer manufacturers under control of the DRAP on emergency situation which restricted its production to Drug Manufacturing License holders. However, it’s an industrial product and falls in personal care category and industrial manufactures are producing it in Pakistan. Aleem Memon further said as it was emergency situation, the PSQCA after three months will approach the government for mandatory inclusion of hand sanitizer in its purview. Earlier, there were no regulations for the hand sanitizers in the country and only provincial industries departments after fulfillment of requirements allowed the industry to produce it. Ethanol is the major component in its making so the provincial industries department also did not issue the licence of hand sanitizer manufacturing easily. Pakistan’s production of ethanol is approximately 500,000 tons per annum and less than 5 percent of this is consumed within the country while 95 percent is exported.