CM to approve amendments in Drug Rules 1982

* KP govt decides to amend rules as they are not able to cope with present challenges

CM to approve amendments in Drug Rules 1982

PESHAWAR: The Khyber Pakhtunkhwa Law Department has duly vetted the proposed amendments in Drug Rules 1982 which will soon be sent to the Chief Minister for final approval.

The health department, on the directives of senior minister health Shahram Tarakai has proposed various amendments in the said rules with the aim to effectively regulate/ monitor the sale and purchase of medicines in the province.

Rules encompassing issues of sale/purchase of drugs were notified way back in 1982 named as "NWFP Drugs Sale Rules 1982" and since then no amendments have been made that could effectively regulate the business to benefit public at large.

The provincial government has decided to amend the Drug Rules 1982 on cogent reasons as these rules are considered to be obsolete in nature and they do not provide explanations of important segments to cope with present scenario and challenges.

The same was observed on various occasion by Provincial Quality Control Board while scrutinizing cases of Drug Inspectors before referring them to Drug Court for judicial trail.

The proposed amendments lay down some specific strict criteria for drug sale outlets including medical stores, pharmacies and whole sale stores in the province.

According to the proposed amendments it is compulsory for sale person of a medical store and pharmacy to be a graduate or diploma holder in pharmacy and with valid license from the concerned regulatory body whereas sale person of a whole sale store must not be less than a pharmacy graduate having valid license.

As long as a medical store, pharmacy shop or whole sale store remains opened, the presence of sale person with the afore said prescribed qualification will be a must; the amendments further propose.

The proposed amendments make it binding on pharmaceutical companies/ manufacturers to supply medicines only to medical stores, pharmacies and whole sale stores wherein duly qualified and license holder sale persons are dealing with sale matters.

It also makes it compulsory for the owners/ operators of medical stores, pharmacies and whole sale stores to display their registration certificates and licenses in visible places in the premises. It has also been proposed in the amendments to ban sale of high doze specific medicines by sale outlets without the proper prescriptions of qualified doctors.

The proposed amendments also make it compulsory for the drug sale outlets to have signboards with prescribed color scheme. As per the prescribed color scheme of signboards, medical stores will have green colored signboards with writings in white; pharmacies will have red colored signboards with writings in white whereas whole sale outlets will have blue colored signboards with writings in black.

Similarly, the amendments make it binding that these sale outlets will have proper concrete structures, design and size and will not be exposed to sun light and dust etc.

Moreover there would be proper arrangement for cleanliness and refrigeration to maintain the required level of temperature for the storage of temperature sensitive medicines.

Matters related to issuing of licenses to pharmacists and its renewal by Drug Inspectors has also been streamlined in the proposed amendments. The new amendments make it binding for drug inspectors to issue license to the applicants and renew it within the stipulated time frame.

It merits a mention here that under section 44 of Drug Act 1976, framing of drug rules and amendments therein is the mandate of the provincial governments.