Sardar Muhammad Sarfraz Dogar, J. Through this petition, the petitioner is seeking quashment of FIR No. 232 dated 21.05.2015 registered under Sections 23 / 27 of Drugs Act, 1976 at Police Station Baghdad-ul-Jadid Bahawalpur.
2. The case was registered against the petitioner by accusing him of manufacturing medicines, without license, using nine different ingredients, which were taken into possession, and the same have also been mentioned in Form-5, thereafter, it was held that he disregarded law, and had been a violator of Sections 27 (1) (a) 30 (2) of Drugs Act, 1976, which is cognizable offence, so the petitioner, being aggrieved at this wrong-doing has invoked the Constitutional jurisdiction for quashment of FIR.
3. Brief facts of this case diagnosed are that the petitioner is running a business under the name and style of M/s Native Food Works and Chemicals (Food Division) Bahawalpur, which is duly registered under the Companies Ordinance as a firm. He is also a taxpayer having NTN No.4243098-4, and his company was manufacturing food supplements, chemicals and medicines etc. By using nine ingredients, later on, which were taken into possession. The detail of those ingredients used in the food supplements is given below:- i. Ascorbic Acid ii. Calcium carbonate iii. Citric Acid (Anhydrous) iv. Dextrose (Monohydrate) v. Sodium Bicarbonate vi. Orange Red Food Colour vii. Sachet Foil Rol printed Calvit+C viii. Outer Carton printed Calvit+C ix. Super Calvit+C sachet
4. The same were taken into possession by respondent No.3 who is Drug Inspector / controller. As a matter of fact, this action of respondent No. 3 is called in question before this Court. The petitioner being aggrieved for the registration of said criminal case, voiced the matter through this constitutional petition.
5. It has been argued by learned counsel for the petitioner that the Government of Pakistan Drug Regulatory Authority, vide its notification No. SRO. 412 (1) 2014 made rules tilted Alternative Medicines and Health Products (Enlistment) Rules, 2014 dated 27.05.2014. And, it is crystal clearly mentioned in Schedule - B Rule 10 (4) of the table namely permitted excipients that additives, preservatives, anti-oxidants, coloring agents, flavouring agents and alternate sweeteners are permitted in medicines including Unani medicines as per referred standard or grade under the Prevention of Food Adulteration Act India (PFA), Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), United States National Formulary (USNF) and others as mentioned in column (3) of the table namely such as:- i. Calcium Carbonate (PFA) ii. Citric acid and its salts (PFA) iii. Dextrose (PFA) Glucose (PFA) iv. Sodium Bicarbonate (PFA) v. Ascorbic acid and its salts and esters (PFA)
6. According to the said notification, the first salt taken into possession is ascorbic acid, which is duly mentioned in the table of antioxidants along with other salts like calcium carbonate, citric acid (anhydrous), dextrose (monohydrate), sodium bicarbonate, orange and red food color, but the Drug Inspector exercising his reason and powers stretched all the above ingredients under the definition of drugs items, which do not fall under Sections 23 and 27 of Drugs Act, 1976, therefore, it is clear that these sections of Drugs Act, 1976 are not attracted in this case of the petitioner, and the trial under this act would amount to an abuse of the process of law.
"The aim of reason is always the good, and this, therefore, is the objective of the state and its laws".
(Plato)
7. On the other hand, the learned Addl. Advocate General accompanied by Drug Inspector argued that items taken into possession were being used in manufacturing the medicines, and fall within the definition of the drugs. As the ingredients, not licensed were being used to manufacture the medicines, that is why the petitioner has committed the offence under Sections 23 and 27 of the Drugs Act, 1976, and is liable to be proceeded under the relevant provisions of law.
8. We have heard learned counsel for the parties and read between the lines the available record.
9. This Court has conspicuously considered the matter to confirm whether these items do fall within the ambit of "Drugs" or "Food Supplements".
10. Precisely, It can vividly be asserted with reference to notification dated 27th May, 2014 given under schedule B, rule 10 (4), in which aforesaid items are "not prohibited items" rather "permitted excipients" like additives, preservatives, anti-oxidants, colouring agents, flavouring agents, alternate sweeteners, and have been mentioned in the table of "permitted excipients".
11. Moreover, calcium carbonate is reflected at serial No. A- 8. Citric acid and its salts are listed at serial No. A-15. Dextrose is mentioned at serial No. A-19. Glucose is written at serial No. A-22, and sodium bicarbonate is named at serial No. A-61 respectively in the said table. Ascorbic acid and its salts and esters are listed at serial No. C-1 in Antioxidants. And, it is clear that Government of Pakistan has established the Drug Regulatory Authority, vide Gazette notification No 9 (12) / 2012- Legis. Dated 13.11. 2012 as Act No XXI of 2012, defined in Clause xv such as:- "Health and OTC Products (non-drugs) include probiotics, disinfectants, mutational products, food supplements, baby milk and foods, medicated cosmetics, medicated soaps and medicated shampoos".
12. Furthermore, the definition of Clause (h) is also reproduced here such as:- "Director Health and OTC Products (non-drugs) who shall be responsible for the assessment, licensing and registration of Alternative Medicines such as Ayurvedic, Chinese, Unani and Homeopathy, enlistment or registration of nutritional products and food supplements for human beings, animals, and also to perform other functions connected therewith".
13. With accordance to the definitions quoted in the Gazette of Pakistan and its notification dated 13.11.2012, as it later transpired that the medicines mentioned above are required to be enlisted as nutritional products / food supplements, and these may be used in making Ayurvedic, Chinese and Unani medicines. For this purpose, the petitioner submitted an application on 13.02.2015 to the Secretary Drug Regulatory Authority, Islamabad for enlistment of natural product of M/s Native Food Works and Chemicals (Food Division) Bahawalpur, which is pending adjudication, and in this regard, the proper fee has also been deposited. Moreover, the same was received by the Statistical Officer in District Coordination office, and it has been further observed that the certain samples were sent to Public Analyst of the Government of the Punjab, Health Department for Multan Zone, who certified in his report No. 2165, dated 13.3.2012 that the sample numbers mentioned in his report are confirmed to the standard prescribed under the West Pakistan Pure Food Rules, 1965.
14. In the light of the above marked facts and circumstances, this Court inferred the conclusion that the ingredients taken into possession by the respondents are organic nutrients used in manufacturing food supplements in petitioner's firm. Here are some standarized definitions of the term 'food supplement' as provided by the Committee on the Framework for Evaluating the Safety of Dietary Supplements, Food and Nutrition Board, Board on Life Sciences, Institute of Medicine and National Research Council of the National Academies. Dietary supplements a framework for evaluating safety Washington, D.C etc. Given in the encyclopedia of Wikipedia that food supplements are products which are not pharmaceutical drugs, food additives like spices or preservatives, or conventional food meeting any of this criteria:- I. The product is intended to supplement a person's diet, despite it not being usable as a meal replacement.
II. The product contains a vitamin, dietary element, herb used for herbalism or botanically used as a medicine plant, which contributes to other food eaten, or any concentrate, metabolite, ingredient, extract, or combination of these things.
15. The major ingredient used in food supplement is ascorbic acid, an antioxidant ingredient which has also been defined and explained by "Safety (MSDS) data for ascorbic acid", Oxford University that ascorbic acid is a naturally occurring organic compound with antioxidant properties. It is a white solid, but impure samples of it can appear yellowish. It dissolves well in water to give mildly acidic solutions. Ascorbic acid is one form ("vitamer") of vitamin C. It is a vitamin found particularly in citrus fruits and green vegetables. It is essential in maintaining healthy connective tissue, and is also thought to act as an antioxidant. And also, severe deficiency of it causes scurvy. Ascorbic acid and its sodium, potassium, and calcium salts are commonly used as antioxidant food additives.
These compounds are water-soluble, and thus cannot protect fats from oxidation. For this purpose, the fat-soluble esters of ascorbic acid with long-chain fatty acids (ascorbyl palmitate or ascorbyl stearate) can be used as food antioxidants. Eighty percent of the world's supply of ascorbic acid is produced in China, as in the case of petitioner, the same has been imported from china, which is further duly confirmed by the system analyst's report.
16. Similarly, the rest of the ingredients like calcium carbonate, citric acid and its salts, dextrose, glucose and sodium bicarbonate are also glucose, and it is a simple sugar which is an important energy source in living organisms, and is a component of many carbohydrates. Dextrose is a form of glucose derived from starches. It is one of the most commonly used ingredients in packaged foods because of its affordability and wide availability. Dextrose may be processed from various types of starchy plants. These also include starching from corn, wheat and rice.
17. Furthermore, sodium bicarbonate is a soluble white powder used as fire extinguishers, effervescent drink and a raising agent in baking. Citric Acid is a sharp-tasting crystalline acid present in the juice of lemons and other sour fruits. It is made commercially by the fermentation of sugar and used as flavour setting agent.
18. Keeping in view the above definitions and explanations of various ingredients discovered, and taken into possession by Respondent No 3 from the premises of the petitioner, there is no ambiguity in the mind of the Court that the petitioner was not involved in manufacturing medicines / Drugs, but food supplements, which involved nutraceutical / natural homeopathic products. Thus, they are not dangerous to humans and animals, therefore do not fall within the ambit of drugs, and consequently, it is not a subject of Drugs Act, 1976. However, it is evident from report of Government Analyst that all samples taken into possession from premises of petitioner were being used in manufacturing food supplements in his firm as a homeopathic / nutraceutical food supplement.
And, these ingredients / salts are not substandard, spurious. Henceforth, they do not fall within the definitions given in Sections 23 and 27 of Drugs Act, 1976, thus no proceedings could have been initiated against the petitioner under the umbrella of Drugs Act, 1976, however, if any substandard process is likely to be involved in manufacturing of these supplements, then the Drug Regulatory authority has no jurisdiction to interfere in the food business, which falls under the domain of the Punjab Food Laws, and the proceedings could only be initiated under Food Laws. In the light of the above inferred conclusions, this petition is allowed, and FIR No.232 / 2015 dated 21.05.2015 under Section 23 / 27 of Drugs Act, 1976 registered at Police Station Baghdad-ul-Jadid, Bahawalpur is hereby quashed.