Assessment of knowledge about nutraceutical regulations and practices among nutraceutical manufacturer and pharmacies

The Pakistani nutraceutical industry faces challenges in regulating its products due to insufficient knowledge among manufacturers and pharmacies, despite the Drug Regulatory Authority of Pakistan's 2014 regulations.

This study aims to assess the level of knowledge and practices regarding nutraceutical regulations among nutraceutical manufacturers and pharmacies in Pakistan. It explores the impact of regulatory practices on the manufacturing, sale, and quality of nutraceutical products.

A cross-sectional study was conducted involving 20 nutraceutical manufacturing units across Pakistan and 100 pharmacies and medical stores located in Lahore. Data were collected through a combination of online questionnaires and in-person interviews.

71.4% of nutraceutical manufacturers in Lahore demonstrated knowledge about the basic definition of nutraceuticals.92.9% of manufacturers in Lahore were aware of the purpose of SRO 412, which regulates herbal, Unani, homeopathic, and nutraceutical products. 64.3% of manufacturers in Lahore understood the significance of product stability during shelf life, while this knowledge was 100% in Peshawar and Islamabad. 90.4% of pharmacies had a pharmacist present, whereas 33.3% of medical stores did not have a pharmacist.74.1% of the pharmacies required prescriptions for nutraceutical sales when pharmacists were present, but only 27.4% of medical stores required prescriptions when pharmacists were absent.

The findings highlight the gaps in regulatory knowledge and staff qualifications in the nutraceutical industry, which could compromise product safety and efficacy. Although some regulations are in place, enforcement and education are key issues. The absence of pharmacists in certain settings further complicates compliance with regulations, especially regarding product safety and labelling.

The study underscores the need for improved regulatory education and enforcement in Pakistan's nutraceutical sector. Enhanced training for manufacturers and pharmacies, coupled with stronger regulatory support from DRAP, is essential to ensure the safety and quality of nutraceutical products in the market.