2020 PLP 324 (MLD)

NAEEM AKHTAR AFGHAN, J.

This judgment disposes of Criminal Misc. Quashment Petition No.364 of 2019, wherein the petitioners have claimed the following relief: "It is therefore respectfully prayed that keeping in view the above submission made therein, that the applicants/accused may kindly be acquitted from the charge leveled against them in the interest of justice, equity and fair play. "

2. After hearing learned counsel for the petitioners, learned AAG-III and Drug Inspector, we have perused the available record which reveals that on 26.3.2011 Drug Inspector Naseerabad took sample of Maxzin Syrup (Zinc Supplement) from Al-Umar Medical Store Quetta Road Dera Murad Jamali, which was manufactured by Reign Nutro Pharma (Pvt.) Ltd., Karachi.

3. Chemical analysis of the sample syrup revealed that it was not substandard as it contained Elemental Zinc with purity percentage of 92.84% as compared to the required limit of 90-110%.

4. Prosecution sanction was granted by the Provincial Quality Control Board Balochistan Quetta to the Drug Inspector Naseerabad on 23.12.2016 for filing a complaint before the Drug Court Balochistan (hereinafter "the trial Court") against the petitioners for contravention of section 23(1)(a)(vii) read with section 27(1)(a) and section 34 of the Drugs Act 1976 (hereinafter "the Act") on the ground that the sample syrup (Zinc Supplement) is unregistered.

5. In pursuance of above, complaint No.40 of 2017 was filed before the trial Court against the petitioners under section 23(1)(a)(vii) read with section 34 read with section 27(1)(a) of Act, wherein the petitioners submitted an application 265-K, Cr.P.C. for their acquittal on the ground that the sample syrup is a non-drug and it is a food supplement as defined under Drug Regulatory Authority of Pakistan Act, 2012 (hereinafter "the DRAP Act"); that the petitioners cannot be prosecuted under the provision of the Act.

6. The above application of the petitioners has been rejected by the trial Court vide impugned order dated 18.3.2019 whereafter the petitioners have filed the instant petition.

7. Record reveals that M/S Reign Pharmaceuticals PCSIR KLC (Pvt.) Ltd., Karachi was granted license on 28.11.2012 to manufacture drugs registered under the Act.

8. The Central Licensing and Drugs Registration Board in its meeting dated 23.12.2006 had already exempted food supplements from section 7 of the Act for the purpose of registration with stipulation that quality control and other parameters will be regulated under the Act.

9. DRAP Act was promulgated on 13.11.2012 and the Alternative Medicines and Health Products (Enlistment) Rules 2014 (hereinafter "the Rules") were framed/notified by the DRAP vide notification dated 27.5.2014. Rules 2(1) (xxxi), (xxxiii) and (lxiii), being relevant, are reproduced herein below:-- "(xxxi) "Food supplements" or "dietary supplement" or "health supplement" or "Nutraceuticals" means products containing vitamins, pro-vitamins, multivitamins, minerals including a mineral salt, a naturally occurring mineral, metals and their salts, a lipid, including an essential fatty acid or phospholipids liproteins, amino-acids, proteins, fatty acids, carbohydrates, a mucopolysaccharide, plant or herbal material (or a synthetic duplicate of that kind), including plant fibers, enzymes, algae, fungi, cellulose and derivatives of cellulose and chlorophyll, herbal preparation, resins, balsams, volatile oils, non-human animal material (or a synthetic duplicate of that kind) including dried material, bond and cartilage, fats and oils and other extracts or concentrates, a microorganism, whole or extracted, except a vaccine expressed juices, exudates etc., alone or their combinations and are presented in pharmaceutical dosage forms intended for health related purpose; " "(xxxiii) "health products" means health and OTC products (non-drugs) as defined in the DRAP Act and include pro-biotic, pre-biotic, disinfectants, food supplements, nutritional products, baby milk and foods, medicated cosmetics, medicated soaps, medicated shampoos, medicated plasters and derma-care products or any other product which may be notified in official gazette by DRAP as Health and OTC Products;" "(lxiii) "nutritional supplements" means a product that is used to supplement a diet beyond that of normal nutrients to support or maintain the healthy body functions in humans and animals;" Zinc is an essential "mineral" which our body does not make on its own. This essential mineral is naturally present in some foods, added to others and available as a dietary supplement. Zinc also supports normal growth and development during pregnancy, childhood and adolescence and is required for proper sense of taste and smell. We can take Zinc supplements or multi-nutrient supplements that provide Zinc. Because of its role in the immune function, Zinc is likewise added to some nasal sprays, lozenges and other natural cold treatments.

10. After promulgation of DRAP Act dated 13.11.2012 and the Rules, the matter pertaining to enlistment of the "food supplements", dietary supplements", "health supplements" and "nutraceuticals" falls within the jurisdiction of DRAP and same cannot be dealt with under the provisions of the Act.

11. While rejecting the application of the petitioners under section 265-K, Cr.P.C. the trial Court has failed to appreciate that on 23.12.2016 the Provincial Quality Control Board Balochistan Quetta had no jurisdiction to grant prosecution sanction to the Drug Inspector for filing a complaint under the provisions of the Act against the petitioners for non-registration of the sample syrup (Zinc Supplement). Had the prosecution sanction been granted to the Drug Inspector by the Provincial Quality Control Board Balochistan Quetta prior to promulgation of DRAP Act and had the sample syrup been spurious or substandard, the situation would have altogether been different.

12. After promulgation of the DRAP Act on 13.11.2012 and the Rules, the prosecution of the petitioners under the provisions of the Act for non-registration of the sample syrup (Zinc Supplement) in complaint No.40 of 2017 filed by the Drug Inspector Naseerabad before the trial Court on the basis of prosecution sanction dated 23.12.2016 of the Provincial Quality Control Board Balochistan Quetta is not maintainable. For the above reasons the petition is accepted. The proceedings pending against the petitioners before the Drug Court Balochistan Quetta under section 23(1)(a)(vii) read with section 34 read with section 27(1)(a) of Drugs Act, 1976 are hereby quashed and the petitioner Nos.2 and 3 are acquitted of the charge. SA/138/Bal. Proceedings quashed.