1. On the allegations of illegally diverting commercial quantity of medicinal tablets, with Tramadol as the main ingredient, which is a prohibited substance under Narcotics Drugs and Psychotropic Substances Act, 1985, the petitioners, who are proprietors of the manufacturing firm, M/s Orison Pharma International, apprehending arrest, came up before this Court under Section 438 CrPC, seeking anticipatory bail.
2. The bail petition was listed for the first time on 4th June 2021, in the pre-lunch session. This Court had issued notices and asked the State to file a status report immediately for consideration on interim relief and posted the matter in the post- lunch session. Even in the post-lunch session, the matter was passed over because the learned Additional Advocate General informed the Court that they have repeatedly informed the concerned police station to file a status report, but failed to receive it. Since the State did not file the status report, this Court was constrained to give interim relief to the petitioner until the next date because one of the petitioners was a woman. After that, the status report was filed on the next date. The interim order is still continuing. It is also not in dispute that the petitioner is regularly joining the investigation, and the status report does not complain of non-co operation in the investigation.
3. Vide order dated 30-05-2021, Assistant Drugs Controller- cum-Licensing Authority, HQ. at Nahan, District Sirmaur, HP, issued a show cause notice and stopped the production orders to M/s Orison Pharma International, a firm in which the petitioner is a proprietor. Such orders were passed because of seizure of huge quantity of Celcidal 100 SR Tablets, containing Tramadol HCl, by the Police of Ajanala, Punjab. Prima facie, as per the printed inscriptions on the tablets, M/s Orison Pharma International was the manufacturer, with inscription marketed by M/s P.P. Pharma, A-1, Park Plaza, Bandra East, Mumabi. On inspection, various drugs were found, and the firm could not produce the required records leading to the order mentioned above.
4. On 2.06.2021, FIR No.52 was registered in Police Station Kala-Amb, District Sirmaur, H.P. The Information mentioned in the FIR states that on 30.05.2021, a police team from Police Station Ajnala, District Amritsar, Punjab, visited Kala- Amb to investigate FIR No.196 of 2021, dated 29.05.2021, registered under Sections 22, 25 and 27A of the Narcotics Drugs and Psychotropic Substances Act, 1985, after now called as ‘NDPS Act’, in Police Station Ajnala, District Amritsar, Punjab. The aforesaid Police officials sought assistance from the Drugs Inspector as well as the Police of District Sirmaur. On this, the Officer-in-Charge of the police station and other police officials visited the premises of Orison Pharma International, situated at Mauza Kheri, Kala Amb, where the investigating team from Punjab wanted to carry out an investigation. During investigation conducted by Punjab Police, the Officer-in-Charge of Police Station, Kala Amb, acquired information that Ajnala Police had seized 4500 tablets of Celcidal TM-100 SRNRX Tramodol Hxdroxichloride-100 mg. The investigator of Ajnala Police Station gave notice under Section 91 CrPC to the owner of the firm Orison Pharma International. The Officer-in-Charge of Police Station Kala Amb also realized that Assistant Drug Controller Nahan had earlier issued a show-cause notice to stop the production to the firm M/s Orison Pharma International. Furthermore, the Drug Inspector seized the tablets from the manufacturing unit under Section 50(1)(c) of the Drugs and Cosmetics Act, 1940.
5. The investigation revealed that Orison Pharma International had manufactured the Celcidal TM-100 SRNRX Tramodol Hxdroxichloride-100 mg, which contains Tramadol with inscription (Marketed by PP Pharma A-1 Park Plaza Bandra (E) Mumbai) and also on some tablets with inscription marketed by New Care Healthcare, Shop No.103, Near Namaste Circle Sahibabagh Ahmedabad-380001. After that, the investigator of Kala Amb tried to get the initial information about these two marketing firms. He received information from Police Station Madhavpura, District Ahmadabad, Gujarat, revealing that the marketing name of the firm New Healthcare does not exist at that address. However, the investigator did not receive any e-mail from Mumbai Police Station. But, on the phone, officials of the concerned Police Station informed the investigator of Kala Amb that such a marketing firm named PP Pharma does not exist at the address described above. Given these conditions, the investigator had reasons to believe that Orison Pharma International had shown these tablets to be marketed by those firms, which do not exist.
6. On 4.6.2021, the In-charge of Police Station Kala Amb forwarded a report under Section 57 of NDPS Act to the Additional Superintendent of Police, District Sirmaur at Nahan. Apart from reproducing the contents of FIR, this report further mentions that on 2.6.2021, the In-charge of Police Station Kala Amb had taken over the tablets seized by Drug Inspector on 30.5.2021. On this, the Drug Inspector had produced such tablets to the Investigator. The report under Section 57 further mentions that the packing material and wrapper discloses the name of PP PHARMA PARK PLAZA (E) MUMBAI AND NEW CARE HEALTH CARE AHMADABAD (GUJARAT). As per the report, these companies were not in existence on their addresses. After that, the Investigator had seized the said tablets, and apart from that, the Investigator also seized seven bags of Tramadol tablets. The Investigator also recovered wrapping material and carton, which also mentions “PP Pharma and New Care Health Care.” The Investigator filled up the NCB Forms and handed over the same to one, Ranbir Singh. The special report concludes that the investigation is in progress, and the Investigator is procuring the relevant documents so that further investigation is carried out to determine how these drugs were manufactured in the names of marketing firms that are not in existence.
7. A perusal of the Police file revealed that the Investigator had produced the case property before learned Chief Judicial Magistrate, Nahan, in compliance under Section 52(a) of the NDPS Act for preparation of Inventory. On 15.6.2021, the police team has gone to Rajasthan because the license of New Care Health Care has been issued from there. Furthermore, the medicines were also dispatched to the said address.
8. The Police file contains a document dated 3.6.2021, written by Assistant Director, Delhi Zonal Unit Narcotics Control Bureau to Station House Officer of Police Station Kala Amb, Sirmaur. As per this document, the Narcotics Control Bureau had seized Tramadol Capsules from the store of one Transport Company, NOIDA, on 2.6.2021. As per this document, the drug's manufacturer is Orison Pharma International, and it was to be marketed by PP Pharma Mumbai. There are supporting documents, which prove the transportation of such drugs by Orison Pharma to Mansi Medicos, Delhi. Another letter dated 3.6.2021 addressed by Station House Officer of Police Station Kala Amb, Sirmaur to Zonal Officer, Narcotic Control Bureau, Delhi. In this letter, Station House Officer of Police Station Kala Amb, Sirmaur, has stated that during the investigation, it came to their notice that the consignment of Tramadol Capsules refers to above were transported in an unauthorized way. A perusal of the police file refers to an investigation conducted on 15.6.2021; as per this report, the Investigator on scrutiny of documents mentioned transactions with 17 different firms. The document further refers to purchase bills, and as per them, on 17.4.2021, Five Hundred Kgs. of Tramadol Powder was purchased by Orison Pharma from a firm of Telangana. A perusal of the documents refers to the purchase of a massive quantity of Tramadol Capsules in tones.
9. On 23.06.2021, this Court had passed the following order: -
“The accused is present in the Court and he need not to remain present in the Court unless explicitly directed to remain present. Mr. Nand Lal Thakur, learned Additional Advocate General, had passed on the investigation file to this Court through Court Master. I have perused the same and the case file is returned as it is to him. I have also dictated notes from the police file for future reference, if any.
To decide the present bail petition, it is necessary to go through the following documents.
Given above, the Investigator to file fresh and limited status report and also to comply with the following directions and handover the documents mentioned hereinafter: -
(i) The latest investigation about the authenticity of address of “PP Pharma, A-1, Park Plaza, Bandra, East Mumbai”.
(ii) Latest verification of address of “New Care, Healthcare, Shop No.103, Near Namste Circle, Sahibabagh, Ahmadabad, 380001”.
(iii) To produce the complete reports of the inspections carried out by the Drug Controller of the State of H.P. or under its orders, and inspections carried out by the concerned Drug Inspectors in the premises of Orison Pharma International, Village Kheri, Mouza Khari, Kala Amb, District Sirmour, H.P. from the date of its inception i.e., 1.7.2017 till date.
(iv) The audit conducted by any Department of the State of H.P. or Central Government about the purchase, manufacturing and sale of the tablets Celcidal TM 100 of Orison Pharma International.
All the information be positively produced on the next date of hearing.
The petitioner shall join the investigation as and when called by the investigator and this Court is not fixing any actual date to do so. It is for the investigator to call the petitioner as per need of the investigation.
List on28.06.2021. Till then, interim order to continue.”
10. The status report dated 27 June 2021 mentions that the petitioners are joining the investigation. It concludes that the investigation carried out reveals irregular export and sale of these medicines containing Tramadol, and a massive quantity of intoxicating tablets have been manufactured in the names of such firms which never existed.
11. On 28.06.2021, the State filed a fresh status report. In answer to the previous order dated 23.06.2021, the status report on the first query states that on 02.06.2021, the Inspector of police BKC Police Station Mumbai informed through e-mail that the firm PP Pharma does not exist at the address.
12. In response to the second query, the status report reveals that on 02.06.2021, In-charge of Police Station Madhopura, had informed that such firm did not exist at the address. The investigation further reveals that the medicines, which M/s Orison Pharma International had sent to M/s New Care Health Care, were sent on the address of Shastri Nagar, Badmer, Rajasthan, because in the purchase order, the address for transportation was mentioned as Rajasthan. The investigation further reveals that New Care Health Care firm is in the proprietorship of one Babu Lal, and he had taken the premises on rent and obtained GST Number. The investigation found the GST Number to be genuine. Furthermore, the investigation found the drugs license number to be genuinely issued from Drug Controller Badmer. However, the landlady disclosed that she had not noticed the transportation of any drugs on these premises. The report of the local drug inspector was also obtained. However, the investigation found the vehicle carrying drugs to have crossed the Toll Barrier Nimbayani at Badmer on five occasions, in which medicines were transported. When the Investigator tried to contact Shri Babu Lal, who was New Care Health Care firm’s proprietor, his phone was found switched off. The investigation is continuing that how said Babu Lal had further sold such drugs.
13. In response to the third query, the status report reveals that Superintendent of Police, Sirmaur wrote a letter to the Drug Controller of the State for obtaining audit report of M/s Orison Pharma International Kala Amb w.e.f. 10.07.2017. In response to that, the Assistant Drug Controller, Sirmaur at Nahan, informed that from 01.07.2017 till date, the department had conducted an audit/inspection of the Orison Pharma International on twenty-seven occasions.
14. In reply to the fourth query, the status report reveals that vide the letter described above, the police sought information from the State/ Central Departments if they have conducted an audit of purchase, manufacture, and sale of Celcidal TM 100 by M/s Orison Pharma International. The Director of M/s Orison Pharma International was also asked vide letter dated 24.06.2021 that whether they got the audit of the firm conducted from any State/Central Department or not. In reply, it is stated that neither the State/Central Department conducted the audit firm nor the firm itself got the same conducted from any agency.
15. The status report further reveals that the investigation is going on about the sale of drugs.
16. Learned Additional Advocate General also placed on record letter dated 28th June 2021, addressed by Assistant Drug Controller to the Additional Superintendent of Police, Sirmaur at Nahan. The contents of the said letter read as under: -
“Subject: -Regarding: - (1) CR.NP) No 1009 of 2021 titled as Ranjna Goyal Vs State of HP. (2) CR.MP(M) No.1011 of 2021 titled as Rakesh Kumar Goyal Vs State of H.P.
Sir.
This is with reference to your letter No. Rdr/Addl.SP/SMR/2021-49610 dated 28.06.2021 on the subject mentioned above. In this regard, the point wise information is as under:
1. As per Rule 52(1) of the Drugs and Cosmetics Rules, 1945, all premises licensed form manufacture of drugs are required to be inspected not less than once in a year. (Copy of relevant page of Act is attached)
2. The inspection of Ms Orison Pharma International, Kala-Amb was conducted at regular intervals by the Drugs Inspector alone or with the Assistant Drugs Controller or with officers of other departments such as CDSCO, Police Deptt., etc. Since 01.07.2017, several inspections i.e. for checking the conditions of the license and provisions of Schedule M and Schedule L-1. Investigation of the Substandard drugs, checking of intoxicants, verification of Technical Staff Competent Technical Persons, etc. of M/s Orison Pharma International, Kala-Amb has been done which are detailed in the Annexure-A. The inspection reports of all the said inspections has already been supplied to your good office vide letter dated 26.06.2021.
3. The inspections of the firm M/s Orison Pharma International, Kala-Amb has been conducted at regular intervals as mentioned in reply of point no. 2 above.
Pointwise information with respect to the letter No. Rdr/Addi.SP/SMR/2021-49703 dated 28.06.2021 is asunder:
1. There is no provision of financial audit under the Drugs and Cosmetics Act, 1940. Hence, no such information is available in this office. This is for your kind information and necessary action please.”
17. Section 8(c) of NDPS Act, mandates that no person shall produce, manufacture, possess, sell, purchase, transport warehouse, use, consume, import inter-State, export inter-State import into India, export from India or tranship any narcotic drug or psychotropic substance, except for medical or scientific purposes and in the manner and to the extent provided by the provisions of this Act or that rules or orders made thereunder and in a case where any such provision, imposes any requirement by way of licence, permit or authorisation, also in accordance with the terms and conditions of such licence, permit or authorisation.
18. Subsection (xi) of Section 2 of NDPS Act describes that the "manufactured drug" means- (a) all coca derivatives, medicinal cannabis, opium derivatives and poppy straw concentrate; (b) any other narcotic substance or preparation which the Central Government may, having regard to the available information as to its nature or to a decision, if any, under any International Convention, by notification in the Official Gazette, declare to be a manufactured drug; but does not include any narcotic substance or preparation which the Central Government may, having regard to the available information as to its nature, or to a decision, if any, under any International Convention, by notification in the Official Gazette, declare not to be manufactured drug;
19. In exercise of the powers vested under Section 2(xi) of NDPS Act, the Central Government vide Notification No. S. O. 1761 (E), dated 26th April, 2018, was satisfied with the scope for abuse of Tramadol, [(natural or synthetic) or natural material or any salt or preparation of such substances or materials], and thus declared Tramadol along with natural material or salts, as a substance under Section 8 (c) of NDPS Act.
20. Per Section 2 (xxiii) of NDPS Act, "psychotropic substance" means any substance, natural or synthetic, or any natural material or any salt or preparation of such substance or materials included in the list of psychotropic substances specified in the Schedule;
21. Thus, the above notification placed Tramadol after serial number 110 X in the Schedule of “LIST OF PSYCHOTROPIC SUBSTANCES”.
22. For the purposes of bail, prosecution and sentencing, the NDPS Act has categorized all drugs and psychotropic substances in three categories, i.e., ‘Small’, ‘Intermediate’, and ‘Commercial’. Section 2 (viia) of NDPS Act states that the "commercial quantity", in relation to narcotic drugs and psychotropic substances, means any quantity greater than the quantity specified by the Central Government by notification in the Official Gazette; and per Section 2(xxiii-a) "small quantity", in relation to narcotic drugs and psychotropic substances, means any quantity lesser than the quantity specified by the Central Government by notification in the Official Gazette. Thus, the quantity that falls between small and commercial quantities is generally referred as “intermediate quantity”.
23. Consequently, the notification dated April 26, 2018, places Tramadol, after serial number 238 ZG in the tabular list mentioning small and commercial quantities of narcotics, drugs, and psychotropic substances. Thus, the entry No. 238 ZG defines quantity lesser than 5 grams of Tramadol as ‘small quantity’ and quantity greater than 250 grams of Tramadol as ‘commercial quantity’. Thus, the Tramadol weighing between 5 grams up to 250 grams (Less than 250 grams) falls in the intermediate quantity.
24. Notification S.O.1055(E) dated 19.10.2001 issued by the Government of India, for Clause (viia) and (xxiiia) of sub clause 2 of N.D.P.S. Act, 1985, provides for a table which mentions all narcotics drugs and psychotropic substances in rows, and every row prescribes its small quantity and commercial quantity. Vide another Notification No.S.O.2942(E) dated 18.11.2009, it is clarified that “The quantities shown in column 5 and column 6 of the Table relating to the respective drugs shown in column 2 shall apply to the entire mixture or any solution or anyone or more narcotic drugs or psychotropic substances of that particular drug in dosage form or isomers, esters, ethers and salts of these drugs, including salts of esters, ethers and isomers, wherever existence of such substance is possible and not just its pure drug content.”
25. In Hira Singh v. Union of India, 2020 Law Suit (SC) 343, a three-judge bench of Hon’ble Supreme Court holds that in case of seizure of mixture of Narcotic Drugs or Psychotropic Substances with one or more neutral substance(s), the quantity of neutral substance(s) is not to be excluded and to be taken into consideration along with actual content by weight of the offending drug, while determining the "small or commercial quantity" of the Narcotic Drugs or Psychotropic Substances. The Court further held that Section 21 of the NDPS Act is not stand-alone provision and must be construed along with other provisions in the statute including provisions in the NDPS Act including Notification No.S.O.2942(E) dated 18.11.2009 and Notification S.O 1055(E) dated 19.10.2001.
26. The active substance is tramadol hydrochloride, and the other ingredients are pregelatinized starch, microcrystalline cellulose (E460), magnesium stearate, etc. Thus, there are neutral materials in the manufactured tablets.
27. When any person manufactures, sells, purchases, transports, finances, or aids Tramadol, such person commits an offence punishable under Section 21 of NDPS Act, even if the pure drug substance is a minuscule percentage of the neutral substances.
28. Per Section 37 of the NDPS Act, the offences involving quantities greater than small quantities are non-bailable offences, which means that the Investigator cannot release the accused on bail upon arrest. The jurisdiction is of the concerned Court to consider the bail. Given such stringent provisions enacted by the Legislature, if a person commits an offence when the quantity of Tramadol found in the contravention is just five grams, which includes the entire substance and not just the pure drug content, such person has to seek bail from the Court, which is mostly post-arrest. Experience tells that the drug dependents stay in jail for quantities that are a pinch above the small quantity, and large sharks keep on recruiting to fill the vacant corners in the supply chains.
29. In the present case, the Punjab Police had seized the drugs manufactured by the petitioner's firm. It implies that in the marketing chain, the drugs got leaked and landed with the drugs mafia. The quantity of Tramadol, purchased by the firm of the bail petitioner, M/S Orison Pharma International, was many quintals and that too of pure drug. If the sale is not strictly under the terms and conditions of the license, it is likely to find its way to the drug mafia. Slight leakage or pilferage would make it a non- bailable offence. Any lapse in regulation or inspection would be catastrophic.
30. A perusal of office order No. HFW-H (Drugs) 122/99 2550-98, placed on the record by the State, reveals that SOP was issued on 4th June, 2021, i.e., only after the seizure and exposure. Whether the delay in issuance of SOP or other necessary orders or instructions by the State Drugs Controller and other persons who were under an obligation to do so was due to COVID-19 pandemic, administrative lapses, sheer negligence, or bonafide would undoubtedly need to be looked into because granting or denying bail to the petitioner need analysis of this aspect. What hindrances stopped the Drugs department of the Central Government from conducting audits or inspections If, based on law, rules, regulations, office instruction, or other records, the Investigators do not find any violation, they may say so in the status report.
31. A perusal of the documents placed on record, i.e. pertaining to the inspection of firm M/s Orison Pharma International, Kala-Amb, w.e.f., 17-01-2018 to 20-11-2020, and joint inspection dated 30-05-2020 reveals that there are no documents or details to find out that whether the tablets containing Tramadol were sold to genuine buyers or the sale was to launder Tramadol. To decide the bail petition(s), it is also necessary to rule out that the sales were made by M/s Orison Pharma International under the bonafide belief and not with any malafide.
32. Furthermore, the seizure of similar drugs by the Punjab Police points out that these drugs were being illegally marketed.
33. Ayn Rand, aptly said in The Fountainhead, “It's easy to run to others. It's so hard to stand on one's own record. You can fake virtue for an audience. You can't fake it in your own eyes. Your ego is your strictest judge. They run from it. They spend their lives running. It's easier to donate a few thousand to charity and think oneself noble than to base self-respect on personal standards or personal achievement. It's simple to seek substitutes for competence--such easy substitutes: love, charm, kindness, charity. But there is no substitute for competence.”
34. The regulators are the lock, stock, and barrel of controlled relaxations by the Sovereign and permissible actions by the subjects. Any lapse, ignorance, softness, kindness, nepotism, favoritism, or speed money can wreak havoc and cause disastrous consequences to the State and society.
35. The FIR reads that the investigator had reasons to believe that these firms would have illegally marketed the tablets even earlier. To rule out that, the manufacturer, i.e., M/s Orison Pharma International of Kala Amb, had entered into a criminal conspiracy and, after concocting the documents, had illegally sold the prohibited substance to other States, which is an offence under the NDPS Act and violation of the conditions of license. Prima facie, the investigator found the owners of Orison Pharma International to have entered into a criminal conspiracy by forging the documents and committed offence punishable under Sections 22, 29, and 8 of the NDPS Act read with Sections 420, 467, 468, 471 and 120B of IPC. After that, the investigator commenced a further investigation.
36. Given above, to enable this Court to decide the bail petition, the State to place on record the material collected by the Investigating Officer about the sale of medicines containing Tramadol by M/s Orison Pharma International, from the date of its inception till date, done to the genuine buyer or fake ones.
37. Apart from the above, the State to place on record the investigation qua paragraphs 2 and 3 of the bail petition Cr.MP(M) No.1009 of 2021, Ranjna Goyal v. State of HP, because she claims to be a sleeping partner and further states that she has no role in the functioning and day-to-day working of the firm.
38. Mr. Nand Lal Thakur, Learned Additional Advocate General submits that such investigation may not have been conducted on this aspect because the case came to the light only upon the seizure of drugs from Punjab. However, he submits that a longer date be given to complete the investigation in terms of this order.
39. Given above, the interim bail is extended till the next date subject to the petitioner joining the investigation as and when called upon to do so.
40. The Office of the Ld. Advocate General to send a downloaded version of this order to the following Ld. officers of the State of Himachal Pradesh: (1) The Chief Secretary, (2) Secretary Home, (3) Secretary Finance, (4) Secretary Personnel, (5) Secretary Health, (6) Secretary Excise and Taxation (7) Secretary Law, (8) Director General of Police, (9) Additional Director General of Police CID and (10) The Director Health, Safety and Regulation; for information because the State of Himachal being a hub of pharma, there may be a likelihood of similar lapses from other manufacturing units, wherein the substances come under the purview of NDPS Act.
41. Counsel for the parties may download the copy of this order along with the case status from the webpage, and if required, authenticate it as true copy.
