ISLAMABAD: There are currently more than 500 alternative medicine manufacturers of which almost 80 percent of the setups do not have testing laboratories.
And if any at all, they have been non-functional due to lack of technical stuff, according to a survey.
After the enactment of the DRAP Act, 2012, for the first time in the history of Pakistan nutraceuticals and alternative medicines were brought under the ambit of drug laws.
In this regard, Alternative Medicines and Health Products (Enlistment) Rules, 2014 was notified and the process of enlistment of nutraceuticals and alternative medicine was started.
According to Enlistment rules, the manufacturer is responsible for quality, safety, and efficacy of the product.
In accordance with this, the DRAP has issued a letter on 27th October 2020 in which instructions to manufacturers of Alternative Medicine regarding the submission of their testing procedure in Drug Testing Laboratories have been given to analyse the quality of Alternative Medicines.
Since the 18th amendment, quality control check has been declared to be the responsibility of the provincial governments.
And yet, none of the provincial governments have made any efforts on ensuring the quality of products.
Medicines prescribed under the name of health boosters of substandard quality to patients are a serious harm to their health.
It is a fact that these medicines containing vitamin, mineral and amino acids require special equipment such as atomic absorption spectrophotometers and the HPLCs and by showing their presence in the factory premises, the said factory was enlisted for manufacture. Now, if the factory is not performing tests on ready for use bulk and on final product, the quality and quantity of the ingredient is not determined.
Absence of ingredient in the final product can lead to false hope given to the patients that they are taking the right nutritional supplement, whereas, improper mixing and over addition or unnecessary addition of some contaminants may lead to the damage to the patient’s organs such as liver and kidney.
In either case, the violation of the enlistment criteria is breached and the firm is liable to be prosecuted under prescribed rules, an expert told Business Recorder.
As prescribed by the Drug Act, 1976, those units manufacturing Alternative Medicine/pharmaceutical products not having functional laboratories must have their registration cancelled.
Copyright Business Recorder, 2021
Comments
Comments are closed.