2020 M L D 324
[Balochistan]
Before Naeem Akhtar Afghan and Abdul Hameed Baloch, JJ
Messrs RIEGN NUTRO PHARMA (PVT.) LTD. and 2 others ---Applicants
Versus
The STATE ---Respondent
Criminal Miscellaneous Quashment No.364 of 2019, decided on 21st October, 2019.
Drugs Act (XXXI of 1976) ---
----Ss. 7 & 23 ---Drug Regulatory Authority of Pakistan Act (XXI of 2012), S. 23 ---
Alternative Medicines and Health Products (Enlistment) Rules, 2014, Rr. 2(1)(xxxi),
2(1)(xxxiii) & 2(1)(lxiii) ---Criminal Procedure Code (V of 1898), S. 561 -A---Quashing of
proceedings ---Registration of drugs ---Sale of unregistered drug ---'Food supplements' ---'Health
products' ---'Nutritional supplements' ---Scope ---Drug Inspector took samples of syrup
manufactured by petitioners, chemi cal analysis of which revealed that it was not
substandard ---Provincial Quality Control Board granted sanction to the Drug Inspector to file
a complaint before the Drug Court for contravention of Ss.23(1)(a)(vii), 27(1)(a) & 34 of
Drugs Act, 1976 ---Petitio ners sought their acquittal on the ground that the sample syrup was
a non -drug and was a food supplement ---Central Licensing and Drugs Regulation Board had
exempted food supplements from S. 7 of the Drugs Act, 1976 for the purpose of registration -
--Matter pertaining to enlistment of the food supplements, dietary supplements, health
supplements and nutraceuticals which fell within the jurisdiction of Drug Regulatory
Authority of Pakistan and the same could not be dealt with under the provisions of the Drugs
Act, 1976 ---Provincial Quality Control Board had no jurisdiction to sanction prosecution to
the Drug Inspector against the petitioners for non -registration of the sample syrup ---
Proceedings pending before the Drug Court were quashed and the petitioners wer e acquitted
of the charge.
Abdul Zahir for Applicants.
Mir Attaullah Langove, Assistant Attorney General -III (AAG -III) along with Dr.
Amber Noreen, Drug Inspector for Respondent.
Date of hearing: 18th September, 2019.
JUDGMENT
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 appli cants/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 wh ich 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 s ample 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 petitioner s 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 lipi d, 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
conc entrates, 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 an d 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 h ealthy 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
suppl ements" 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 Dru g 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 petit ioners 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 Provinci al 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.This judgment is reproduced from a publicly available source for informational purposes and does not constitute legal advice. If you believe this listing contains an error,
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