About Author:
Mr. Jagmohan Rai Agarwal,
M.Pharm (1968), Industrial experience SSI sector, nearly 37 years,
retired from own Industry (2004),
Founder President of M.P.Pharmacy Graduates’ Association (MPGA),
Ex President: M.P.Pharmaceutical Manufacturers’ Organisation (MPPMO),
Founder President : M.P. Small Scale Drug Manufacturers’ Association (MPSDMA),
Ex President Indian Pharmaceutical Association, M.P. State Branch, Indore (IPA),
Ex Vice Chairman Confederation of Indian Pharmaceutical Industries (SSI) (CIPI)
Recently submitted thesis for award of Ph.D. on title “Enforcement of Drug Laws-Globalization vis-à-vis Indian Drug Laws”
(Email: sharda_jollo@yahoo.co.in)
Literal meaning.
Origin
Absolute monarchies are those in which all power is given to or, as is more often the case, taken by, the monarch. Examples of absolute power corrupting are Roman emperors (who declared themselves gods) and Napoleon Bonaparte (who declared himself an emperor).
"Absolute power corrupts absolutely" arose as part of a quotation by the expansively named and impressively hirsute John Emerich Edward Dalberg Acton, first Baron Acton (1834–1902). The historian and moralist, who was otherwise known simply as Lord Acton, expressed this opinion in a letter to Bishop Mandell Creighton in 1887:
"Power tends to corrupt, and absolute power corrupts absolutely. Great men are almost always bad men."
The scope of this article is limited on the issue “Whether the legislature intended to impose punishment on the Firm / Company and its directors/partners/officials in the event of a drug/batch reported as Not of Standard Quality (NSQ) by the Government Analyst (GA) and/or Director, Central Drug Laboratory, Calcutta, CDL, alleging offence u/s 18(a)(i) r/w sec. 27(d) of the ‘Act’”
The author is of the firm view that based on legal propositions; the answer to the scope of the article is “BIG NO”.
Object of Act & Rules: Drugs are potent things. Modern scientific discoveries of recent years have vastly added to their numbers. With the growing consciousness of the people in their efficiency the need had arisen that the State see to it that the drugs of standard quality and purity are put in the market; that there is no misbranding and fraud and to preserve the public health, they do not impair any fundamental rights of life, liberty or property
In recent years there is a trend that FDA officials in the country very conveniently, without observing provisions of law, in abuse of powers vested in them and contrary to the guidelines prescribed by the Drugs Consultative Committee launch criminal prosecution against the concerned firm/company with directors/partners and many a times on technical staff alleging contravention of section 18(a)(i) punishable u/s 27(d) of ‘Act’ in the event of particular drug, alleged to be manufactured by the firm/company being reported as NSQ by either Government Analyst or Director, CDL.
Let us examine various relevant provisions of Law:
Qualifications of Govt. Analysts and Drugs Inspectors, Licensing Authority and Controlling Authority:
Government Analyst: Graduate/Post graduate in Medicine orScience or Pharmacy or Pharmaceutical Chemistry with experience in testing of drugs of a specified period (Rule 44).
Drugs Inspector: Degree in Pharmacy or Pharmaceutical sciences or Medicine with specialization in Clinical Pharmacology or Microbiology with experience in manufacture, testing of drugs of a specified period (Rule 49).
Licensing Authority: Graduate in Pharmacy or Pharmaceutical Chemistry or in Medicine with specialization in clinical Pharmacology or Microbiology with experience in manufacture or testing of drugs for enforcement of the provisions of the Act for a minimum period of five years (Rule 49-A)
Controlling Authority: Graduate in Pharmacy or Pharmaceutical Chemistry or in Medicine with specialization in Clinical Pharmacology or Microbiology with experience in manufacture or testing of drugs for enforcement of the provisions of the Act for a minimum period of five years (Rule 50)
It is interesting to notice that none of above qualifications and/or experience requires experience in interpretation of standards of drugs, capacity/capability to understand the provisions of Act / Rules. There is no provision in the law for imparting compulsory training in this behalf before such persons are actually given charge of the field. More so there is no arrangement either in the Law or in practice for training of such persons at regular intervals. They are just appointed on the basis of qualifications/experience prescribed and overnight they become BOSS of Industry and Trade.
It is also irony that in few States head of FDA does not meet qualification/experience prescribed and such officials are fully involved in enforcement of the Act/Rules.
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STATE GOVERNMENT TESTING LABORATORIES, CENTRAL DRUG LABORATORY:
It is undisputed fact that in India Test Reports issued by Government Analyst(s) whether belonging to State Lab. or CDL in form 13 of Rules and / or Test Report issued by the Director CDL, Calcutta in form 2 of Rules solely forms the basis of initiating either administrative action under rule 85 of Rules for suspension/cancellation of licence or for institution of criminal prosecution.
These laboratories are required to give opinion whether the drug is of or not of Standard Quality as defined in the Drugs and Cosmetics Act and Rules framed there under.
The apathy of these so called laboratories whose findings decide the fate of Industry and Trade is as under:
Mashelkar Committee Final Report 2003:
1. Out of 31 States/UTs, only 17 drug testing laboratories were found to be functioning. Out of 17 States having their testing laboratories, only 7 were reasonably equipped / staffed, while the others were poorly staffed and did not even have the bare minimum equipment. (Page 2).
2. The limitations in testing of drug samples in the government labs. are related to the absence or lack of sophisticated instruments, lack of trained analysts, lack of commitment, lack of reagents, non-validated methods, shortage of funds, inadequate number of staff and in many cases a combination of more than one of these constrains.(Page 91).
OTHER ISSUES:
(i) None of these government labs. including the CDL have ever been audited what to talk about audit at regular interval.
(ii) There is no arrangement for training at regular interval of government analysts and other junior analysts engaged in testing of drugs.
(iii) The quality of chemicals and reagents are procured without any quality assurance and vendors list is not approved.
(iv) Absence or lack of reference books, other text books and current literature.
(v) Absence or lack of reference standards.
(vi) Lack of capability / Capacity and skill to interpret standards prescribed and provisions of the Act and Rules and there is no practice of imparting training in this regard.
(vii) Absence or lack of sophisticated equipments and trained expert technical staff to handle those equipments.
The entire ‘Act’ has been prepared for the purpose of proper enforcement of the Drugs and Cosmetics Act. There also we find that it is the Drugs Inspectors who have to perform several duties enumerated under the various provisions of the Act. The primary idea is that no substandard drug shall be sold in the market and no one will sell even a genuine drug without a licence. This is the essence of the provisions of the Drugs and Cosmetics Act.
To enforce this central idea various provisions of the Act have been made and officers are appointed primarily for the purpose of enforcement of this Act. (1988 Drug Cases 70 Bombay High Court, DB, State of Maharashtra Vs Laxmichand Varhomal Chugani, Para 12)
As the title of section 18 suggests, it is prohibitory provision. The Oxford dictionary meaning of ‘Prohibition’ is- the action of forbidding something, specially by law’
Section 18(a)(i) as amended by Act of 68 of 1982 w.e.f. 1.2.1983 reading as under-
18 Prohibition of manufacture and sale of certain drugs and cosmetics: From such date as may be fixed by the State Government by Notification in the official Gazette in this behalf, no person shall himself or by any other person on his behalf-
(a) manufacture for sale (or for distribution), or sell, or stock or exhibit (or offer) for sale, or distribute-
(i) any drug which is not of standard quality or is misbranded, adulterated or spurious;
(ii) any cosmetic which is not of standard quality or is misbranded or spurious.
S. 27 as amended in the year 1982 w.e.f. 1.2.1983 reading as under:
27. Penalty for manufacture, sale, etc., of drugs in contravention of this Chapter.—whoever, himself or by any other person on his behalf, manufactures for sale or for distribution, or sells, or stocks or exhibits or offers for sale or distributes,
(a) any drug deemed to be adulterated under section 17A or spurious under section 17B or which when used by any person for or in the diagnosis, treatment, mitigation, or prevention of any disease or disorder is likely to cause his death or is likely to cause such harm on his body as would amount to grievous hurt within the meaning of section 320 of the Indian Penal Code (45 of 1860), solely on account of such drug being adulterated or spurious or not of standard quality, as the case may be, shall be punishable with imprisonment for a term which shall not be less than five years but which may extend to a term of life and with fine which shall not be less than ten thousand rupees;
(b) any drug—
(i) deemed to be adulterated under section 17A, but not being a drug referred to in clause (a), or
(iii) without a valid licence as required under clause (c) of section 18, shall be punishable with imprisonment for a term which shall not be less than one year but which may extend to three years and with fine which shall not be less than five thousand rupees:
Provided that the Court may, for any adequate and special reasons to be recorded in the judgment, impose a sentence of imprisonment for a term of less than one year and of fine of less than five thousand rupees;
(c) any drug deemed to be spurious under section 17B, but not being a drug referred to in clause (a) shall be punishable with imprisonment for a term which shall not be less than three years but which may extend to five years and with fine which shall not be less than five thousand rupees:
Provided that the Court may, for any adequate and special reasons, to be recorded in the judgment, impose a sentence of imprisonment for a term of less than three years but not less than one year;
(d) any drug, other than a drug referred to in clause (a) or clause (b) or clause (c), in contravention of any other provision of this Chapter or any rule made there under, shall be punishable with imprisonment for a term which shall not be less than one year but which may extend to two years and with fine:
Provided that the Court may, for any adequate and special reasons, to be recorded in the judgment imposes a sentence of imprisonment for a term of less than one year.
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S. 27 is further amended vide Drugs and Cosmetics (Amendment) Act 2008 notified on 10th August 2009 reading as under:
27. Penalty for manufacture, sale, etc., of drugs in contravention of this Chapter.—whoever, himself or by any other person on his behalf, manufactures for sale or for distribution, or sells, or stocks or exhibits or offers for sale or distributes, -
(a) any drug deemed to be adulterated under section 17A or spurious under section (17B and which) when used by any person for or in the diagnosis, treatment, mitigation, or prevention of any disease or disorder is likely to cause his death or is likely to cause such harm on his body as would amount to grievous hurt within the meaning of section 320 of the Indian Penal Code (45 of 1860), solely on account of such drug being adulterated or spurious or not of standard quality, as the case may be, shall be (punishable with imprisonment for a term which shall not be less than ten years but which may extend to for life and shall also be liable to fine which shall not be less than ten lakh rupees or three times value of the drugs confiscated, which ever is more);
"Provided that the fine imposed on and released from, the person convicted under this clause shall be paid, by way of compensation, to the person who had used the adulterated or spurious drugs refered to in this clause:
Provided further that where the use of the adulterated or spurious drugs refered to in this clause has cause the death of a person who used such drugs, the fine imposed on and realised from the person convicted under this clause, shall be paid to the relative of the person who had died due to the use of the adulterated or spurious drugs refened to in this clause.
Explanation.- Not being reproduced being irrelevant for the purpose of this article.
(b) any drug—
(i) deemed to be adulterated under section 17A, but not being a drug referred to in clause (a), or
(ii) without a valid licence as required under clause (c) of section 18,
shall be punishable with imprisonment for a term which shall (not be less than three years but which may extend to five years and with fine which shall not be less than one lakh rupees or three times the value of the drugs confiscated, whichever is more):
Provided that the Court may, for any adequate and special reasons to be recorded in the judgment, impose a sentence of imprisonment for a term of (less than three years and of fine of less than one lakh rupees);
(c) any drug deemed to be spurious under section 17B, but not being a drug referred to in clause (a) shall be punishable with imprisonment for a term which shall (not be less than seven years but which may extend to imprisonment for life and with fine which shall not be less than three lakh rupees or three times the value of the drugs confiscated, whichever is more):
Provided that the Court may, for any adequate and special reasons, to be recorded in the judgment, impose a sentence of imprisonment for a term of less than three years but not less than one year;
(d) any drug, other than a drug referred to in clause (a) or clause (b) or clause (c), in contravention of any other provision of this Chapter or any rule made there under, shall be punishable with imprisonment for a term which shall not be less than one year but which may extend to two years (and with fine which shall not be less than twenty thousand rupees):
Provided that the Court may, for any adequate and special reasons, to be recorded in the judgment imposes a sentence of imprisonment for a term of less than one year.
COGNIZANCE OF OFFENCE
Section 32 as amended in the years 1982 and 1986:
S. 32 (1) No prosecution under this chapter shall be instituted except by an Inspector or by the person aggrieved or by a recognized consumer association whether such person is a member of that association or not (Ins.. by Act of 1986 w.e.f. 15.9.1987).
(2) No Court inferior to that of a Metropolitan Magistrate or of a Judicial Magistrate of the First Class shall try an offence punishable under this chapter.( Subs. by the Act 68 of 1982 w.e.f. 1.2.1983)
(3) Nothing contained in this chapter shall be deemed to prevent any person from being prosecuted under any other law for any act or omission which constitutes an offence against this chapter.
Section 32A was amended in the year 1982 as under:
S. 32A Power of Court to implead the manufacturer etc.- Where, at any time during the trial of any offence under this chapter alleged to have been committed by any person, not being the manufacturer of a drug, or cosmetics or his agent for the distribution thereof the Court is satisfied, on the evidence adduced before it, that such manufacturer or agent is also concerned in that offence, then, the Court may, notwithstanding any thing contained (in sub-sections (1),(2) and (3) of section 319 of the Code of Criminal Procedure,1973), proceed against him as though a prosecution had been instituted against him under section 32.( Subs. by act 68 of 1982 w.e.f. 1.2.1983)
Section 32 (1) and (2) are further amended and notified in the year 2009 as under:
S. 32 (1) No prosecution under this chapter shall be instituted except by-
(a) an Inspector; or
(b) any gazetted officer of the Central Government or a State Government authorized in writing in this behalf by the Central Government or a State Government by a general or special order made in this behalf by that Government; or
(c ) the person aggrieved; or
(d) a recognised consumer association whether such person is a member of that association or not.
(2) Save as otherwise provided in this Act, no Court inferior to that of a Court of Session shall try an offence punishable under this chapter.[Drugs and Cosmetics (Amendment) Act 2008 notified vide no. S.O. 2076 (E) dated 10.08.2009]
Abstract from 59th Report on Functioning of the Central Drugs Standard Control Organisation (CDSCO) by Department-Related Parliamentary Standing Committee on Health and Family Welfare- Presented to the Rajya Sabha and Lok Sabha on 8th May 2012
(viii) CDTL, Hyderabad is yet to be equipped, and other five CDL/CDTL at Calcutta, Mumbai, Chennai, Gauhati and Chandigarh were reasonably equipped but not fully equipped and required upgradation with the state-of-the-art facilities for testing / analyzing complex formulations and detect spurious, misbranded, substandard and adulterated drugs.(Para 5.1, Page 20)
(ix) The Ministry admitted that the State Drug Testing Laboratories are not fully equipped with adequate manpower and infrastructure. (Para 5.5, Page 21)
(x) Chennai State Drug Testing Laboratory having only two HPLC bought more than a decade ago which had become obsolete. (Para 5.7, page 21)
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Following a few case studies/examples would reveal the truth:
(a) Government Analyst of DTL of a State considered to be above average in the country declares a sample of ‘ORS I.P.’ Not of Standard Quality (NSQ) in respect of “Description” only in a particular year. Whereas as per General Notices of I.P. in that particular year “Description” is not part of standards when mentioned above the heading Standards in the relevant monograph.
(b) Government Analyst of DTL of another State committed almost the same error by declaring ‘Tabs. Ethambutol I.P.’ as NSQ in respect of ‘Description’ when the relevant monograph of said drug in I.P.does not mention description as part of standards at all.
(c) Director CDL, Calcutta declared sample of ‘Enzymes with vitamins tabs’ as NSQ though results of all other parameters reported were complying prescribed standards. When confronted a corrigendum declaring the sample as of standard quality was issued by the Director, CDL and sent to concern Court.
(d) Drug ‘A’ was manufactured in the year 1999 as per IP 1996 r/w certain amendment list no. 2 issued by DCGI / IPC in July 1997 in respect of test for dissolution. The drug was declared as NSQ in respect of test for dissolution only in the year 2000 by the State Govt. Analyst as per IP 1996. Again Director, CDL, Calcutta upheld the results of Govt. Analyst while adopting IP without mentioning the year of the edition. Prosecution launched by the DI in the sampling State in the year 2003. In the meanwhile the company was transferred to new management in the year 2004 and all relevant original record remained with the company. In considered view of the author both Govt. Analyst and Director, CDL, Calcutta committed error in not following the amendment list no. 2 in respect of test for dissolution.
The matter did not end here. In order to demonstrate before the Court that amendment list no.2 has not been adopted for the test of dissolution, the manufacturer of the said drug enquired from office of the Indian Pharmacopoeia Commission and Drugs Controller General India as well as from Indian Drug Manufacturers’ Association, Mumbai (IDMA) about the exact date in the year 1997 on which the said amendment list no. 2 came into force.
It was surprising that IPC and DCGI being highest officials directly concerned with the issuance of said amendment list no. 2 were unable to provide the copy of said circular. The IDMA claiming to be all India Manufacturers body whose weekly bulletin carried the said amendment with covering letter of DCGI was also unable to trace and provide copy thereof.
If this is the state of affairs in the offices of IPC and DCGI in the country what to talk about poor Govt. Analysts and the Apex Lab., CDL. If they are unaware of latest applicable amendment to particular test in a drug.
(e) Tender requirement by one of the National Procurement Agencies, was for ‘Erythromycin Stearate for Oral Suspension’ 125 mg / 5ml. of Erythromycin. Parties participated for the said drug/specifications with copies of drug licence. At the time of approval, in presence of Asstt. Drugs Controller India (CDSCO), the specifications were managed and changed to Erythromycin Stearate 125 mg/5ml. The successful bidder thereafter managed and obtained fresh licence according to the approved specifications and continued supplies of sub-therapeutic antibiotic preparation meant for pediatric use and lakhs of bottles were supplied across the country. Thus instead of 200mg Erythromycin Stearate/ 5ml (equivalent to 125 mg of Erythromycin) only 125 mg/5ml Erythromycin Stearate (equivalent to about 78 mg Erythromycin) was intentionally manufactured and supplied.
The matter was reported to the procurement agency along with DCGI and all concerned State Drug Controllers. The procurement agency issued circular directing to withdraw the drug of grossly sub-therapeutic potency, revised the specifications already approved, and closed the matter silently. None of the Drug Controllers, including DCGI, even acknowledged the complaint lodged what to talk of taking action against the defaulting manufacturer.
There are innumerable numbers of such case studies where music is being faced by mostly Industries belonging to SME sector. During one of the high level committee meetings conveyed by the then Health Minister Madhya Pradesh in the year 1987 attended by top beaurocates in the Ministry along with delegation of M. P. Pharmaceutical Manufacturers Organisation, Indore lead by the author, the then President of the Association, Shri O. P. Dubey, I.A.S. the then Drugs Controller, M.P. had made a statement saying “That 98% of the prosecution cases launched in the State prior to his taking charge are unwarranted”
Action/Reaction of Drugs Inspector on receipt of NSQ report:
The Drugs Inspector relying on the bottom line of the test report, declaring the drug as NSQ, without examining the same, without studying relevant reference book(s), which are normally not available in his office, in majority of cases proceeds as below.
1. The action/reaction of DI varies from person to person and State to State.
2. Sending of sample portion and original of report to the manufacturer of alleged NSQ drug also depends on person to person and State to State.
3. Copy of the report may also be forwarded to the Licensing Authority FDA of manufacturing State.
4. Depending on his/her whims, DI after complying (?) with provisions of Law may write to the manufacturer of disputed drug to forward copies of records of manufacturing, testing, sale, particulars of Expert Staff, constitution of the firm / company etc.
5. Again depending upon level of EGO / DEAL the DI may either drop further proceedings or refer the matter to the FDA of manufacturing State for further needful action or may launch criminal prosecution for contravention of sec. 18(a)(i) r/w sec. 27(d) of the ‘Act’, mostly in the sampling State which may be at a long distance from the manufacturing place. It is to be remembered that administrative action u/r 85 of Rules only by the manufacturing State legally possible.
It is matter of record that Drugs Consultative Committee (DCC) in its 26th meeting, held on 14th-15 Sept. 1989, vide item no.22 had resolved as under:
“The members agreed that guidelines approved in 22nd DCC (1993 guidelines) meeting should be adhered to as for as possible. However, it should be left at the discretion of the concerned Drugs Controller to file a prosecution in his State or to refer the case to the Drugs Controller of manufacturing State as circumstances warranted. That every Drugs Controller should invariably supply the information sought by other Drugs Controller in case a prosecution is to be launched irrespective whether the Drugs Controller of manufacturing State agrees to the decision of the Drugs Controller where the sample has been drawn to launch prosecution.”
It is above decision of DCC which resulted in launching of prosecutions in other than manufacturing States. In the name of INVESTIGATION in majority cases copies of certain documents like manufacturing, testing, sale & constitution of firm/company etc are asked for.If this is being considered sufficient Investigation for fastening person(s) under criminal law for vicarious liability then there is no effective purpose of appointing Qualified Pharmacists in Regulatory.
The guidelines formulated by the Central Government after Drugs and Cosmetics (Amendment) Act 2008 and forwarded as Directions u/s 33P to all State Governments, just to satisfy the agitating SMEs, is nothing but LOLLYPOP.
Section 33P: The Central Government may give such directions to any State Government as may appear to the Central Government to be necessary for carrying into execution in the State any of the provisions of this Act or any Rule or order made there under
A drug manufactured in Madhya Pradesh and its sample reported NSQ in Karnataka proposed ‘Screening Committee’ of which State shall examine the matter and report to Drugs Controller of which State?
Important Provisions inserted vide Amendment 2009:
1. Constitution of ‘Screening Committee’ of three senior officials not below the level of Asstt. Drugs Controller on whose written opinion the Controlling Authority shall decide course of criminal prosecution.
2. Criminal prosecution shall be launched by the Drugs Inspector after obtaining written permission of the Controlling Authority.
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DRUGS CONSULTATIVE COMMITTEE (DCC)
1. In the year 1993 guidelines in respect of NSQ drugs were circulated amongst all State Drug Controllers.
2. NSQ drugs were divided into ‘Major’ and ‘Minor’ defects and guidelines were issued for taking appropriate actions
3. Investigation is the important part of those guidelines before proposing any action whether administrative or legal.
4. Prosecution was stated to be last resort where all other remedial measures had failed.
GUIDELINES FOR TAKING ACTION ON SAMPLES OF DRUGS DECLARED SPURIOUS OR NOT OF STANDARD QUALITY IN THE LIGHT OF ENHANCED PENALTIES UNDER THE DRUGS AND COSMETICS (AMENDMENT) ACT, 2008 Effective from 10.8.2009.
Legal/administrative actions as required under the said Act and Rules for the violation of the provisions of the Act are taken by the State Licensing Authorities. The actions are normally initiated on the basis of test reports of Government analysts declaring the drug samples as not of standard quality. The major categorization of not of standard quality reports could be as under:-
Silent features
Category A (Spurious and Adulterated Drugs
Category B (Grossly sub-standard drugs)
Category C (Minor defects)
In the case of drugs manufactured by a licensed manufacturer under a valid manufacturing licence has been found grossly sub-standard, the matter may be investigated at the manufacturer’s end, and where criminal intent or gross negligence has been established and if the merits of the case so demand, and where it is felt that administrative measures would not be sufficient to meet the ends of justice, the re-course to prosecution should be resorted to,
In the case of drugs manufactured by a licensed manufacturer under a valid manufacturing licence and found grossly sub-standard and where criminal intent or gross negligence is not established, weapon of prosecution should be used judiciously, where it is felt that administrative measures like suspension or cancellation of licenses or compounding of offences would not meet the ends of justice.
In the case of not of standard quality reports because of minor defects arising out of variations from the prescribed standards or contraventions of other provisions of chapter IV of the Act, administrative measures including suspension/cancellation or compounding of offences may be resorted to. Prosecution may only be launched where it is justifiably felt that above measures would not meet the ends of justice.
The State Drug Control Departments shall constitute screening committees comprising of at least three senior officers not below the level of Assistant Drugs Controllers or equivalent to examine the investigation reports of the cases where prosecutions are proposed to be launched. The committee may submit written opinion on the investigation reports regarding their feasibility of taking legal action.
The criminal intent or gross negligence should be taken into consideration while recommending actions like prosecution etc. Care should be taken that charges framed are not based on inappropriate provisions which may be difficult to prove in the court of law in the absence of proper justification or evidence. Cases of failing in assay, brand name disputes and non-renewal of manufacturing licence in time should be examined on their merits before recommending prosecution in such cases.
Prosecutions by the Inspectors shall be launched on the basis of written permissions of the controlling authority and this authority in turn shall consider the opinion of the screening committee while taking final decision in the matter.
Prosecutions under section 18(a)(i) r/w sec. 27(d), in case drug is declared NSQ, barring some exceptions, are being launched against firms/companies, mostly SMEs’, across the country, no body in the profession is objecting and raising the voice, judiciary is also taking cognizance of alleged offence and criminal matters attracting vicarious liability are dragging in various Courts not only for years but for decades causing undue hardship to so called accused persons in addition to mental agony, torture, humiliation and financial burden.
Well if reporting of a drug as NSQ is the basis for launching the prosecution then nearly 10000 (Ten thousand) samples reported NSQ annually must result in prosecution in each and every case. But it does not happen so and the system of ‘pick and choose’ is being adopted depending on the ‘deal’, size and category of the company and its influence on the FDA, superior officials and political leadership.
The author is of the firm view that simply if a drug is declared as Not of Standard Quality (NSQ) and even if the test report either in form 13 or in form 2 is accepted as it is, there is no contravention of sec. 18(a) (i) and nor legislator has prescribed any punishment u/s 27(d) under such circumstances UNLESS:
It is established, on real investigation
1. That while the drug was manufactured and released for sale/distribution, it was not properly manufactured/tested for some or the other reason, either partially or wholly. OR
2. That the drug is NSQ and falls within the ambit of sec. 27(a) of the ‘Act’. OR
3. That the drug was being sold / distributed even after receipt of adverse test report.
There is no provision in the ‘Act’ for punishment under sub-sections (a), (b), (c) and (d) of sec. 27 if the drug is allegedly declared as NSQ and if findings in the investigation, in above respect, is negative.
Hon’ble Supreme Court while dealing with a case on limitation (State of Rajasthan Vs Sanjay Kumar and Others Drug Cases 1998, SC, 7), under Para 9 have observed as under:
“On the date of collection of samples from respondent no. 16, on February 29, 1988, it could not have been said that any offence was committed as selling of drugs per se is no offence and the quality of drugs was not known to the Drugs Inspector, the complainant on that date. It is only, when the report of the Government Analyst was received, that it came to light that the provisions of the Act are violated and offence is committed.”
Thus it is only on receipt of the adverse test report by the Drugs Inspector, subject to investigation and scrutiny thereof technically, it could be attributed that the offence, if any, is committed. The responsibility could be fastened on person(s) after detailed investigation.
While disposing of bundle of Criminal applications on the issue of tenability of Regular Criminal cases, Hon’ble Bombay High Court, Bench at Nagpur made following observations:
“Looking to the scenario discussed by me above, I conclude that the Food and Drugs Department and its officers from the cadre of Food Inspectors to Joint Commissioner do not have any legal knowledge, legal skill and seriousness with which the provisions of these Acts concerning human health is required. They are casual, callous and hardly concerned. Relevant and concerned provisions/amended provisions of Code of Criminal Procedure are not even known to them to make use thereof.
They are making cases only to show that cases are being prepared and instituted in Courts and finally tell the people that Courts have discharged or acquitted the accused persons and thus save their skin. In my opinion, Government is simply wasting money on Food and Drugs Department and serious view for revamping this department will have to be taken by the Government with strict “accountability” to be fixed for each and every officer”. (Bombay High Court, Nagpur Bench, Cr.Appl. Nos. 3439 of 2006 with Cr. Appl. Nos. 3440 of 2006, 3442 of 2006, 3444 of 2006, 3441 of 2006, 3445 of 2006, 1290 of 2008 and 3443 of 2006)
In the same matter Hon’ble Court, was pleased to direct as below, under Para 23, to the Secretary, Food and Drug Department:
“I have already pointed out in details in para 7,8,9,19,20 & 21 the acts of omissions and commissions on the part of the officers of the department and I clearly find that the officers of the Food and Drug Department in these cases who are public servants have disobeyed the law with intention to cause injury by their acts of omissions and commissions and thus they have committed offence punishable under section 166 of Indian Penal Code.
Since the offence is noncognizable, this Court directs the Secretary, Food and Drug Department, Government of Maharashtra, to identify the concerned officers responsible for the acts of omissions and commissions in all these cases and cause filing of private complaint for the offence punishable under section 166 of Indian Penal Code against them in the Court of law, and report compliance about filing thereof to this Court on or before 31.7.2010”.(www.indiankanoon.com)
A Firm/Company whose drug is alleged to have violated prohibitory provisions under section 18 (a) (i) is invariably sought to be punished under section 27 (d) of the ‘Act’.
Each and every licencee authorized to manufacture drugs for sale or distribution complies with mandatory provisions of Drugs and Cosmetics Rules 1945 (Rules) in as much as that every raw material is utilized in formulation only on its compliance with prescribed standards and the finished goods is released for sale /distribution only when the batch is reported as of standard quality conforming with prescribed standards.
Every licencee maintains proper record of raw material and finished goods as prescribed under ‘Rules’. The testing of raw material and finished goods is conducted either in in-house laboratory of the licencee or in an institution duly approved by the SLAs under the provisions of the ‘Rules’.
In-house testing unit of the licencee and the institution approved by SLAs are subjected to FDA inspections periodically for maintenance of Qualified Staff, Equipments, Instruments, and Methods of analysis adopted, Chemicals/Reagents, floor area etc.
Subsequently on reporting of a drug/batch NSQ by the GA the process begins. The so called ‘Investigation’ carried out by Drugs Inspector (DI) concerned before launching of prosecution in the Court of Law, is nothing but collection of record related to manufacture, testing, sale, constitution of the firm, names and residential addresses of technical staff responsible for the manufacture and testing of disputed drug, licence copies with renewal, if any.
For collection of these records, some State Authorities have adopted a practice (?) to visit the licencee, may be located in other States, with or without the local FDA Authorities. In the meanwhile the SLA in whose jurisdiction the licencee operates normally serves Show Cause Notice (SCN), to such licencee, under rule 85 of ‘Rules’.
Thereafter depending of whims of concerned DI and his superior Authorities, the private complaint (Prosecution) is launched in the Court of Law alleging contravention of sec. 18(a) (i) and seeking punishment u/s 27(d) of the ‘Act’. There is not a single known example in the country where the Court did not take cognizance of the matter applying judicial mind as has been observed by High Courts in number of judgments and dismissed the complaint ab-initio.
It is reiterated that solely on the basis of author’s interpretation of secs. 18(a) (i) and 27(d) that if a drug/batch is reported as NSQ and even if the said report is accepted as it is, and if the relevant batch of the drug is not sold by the licencee thereafter, there is no contravention of sec. 18(a)(i) and sec. 27(d) does not prescribe any punishment in such circumstances. This legal thought is being narrated in sequence as under:
a) The allegation that the accused have manufactured the drug/batch as NSQ and sold/distributed the same as such is unfounded, without any evidence to that effect. On the contrary the record related to manufacturing/testing may or may not be filed with the complaint goes to establish beyond any doubt that the drug/batch when was manufactured and released for sale/distribution, was of Standard Quality. There is practically no specific allegation that what material in those records would be treated as supportive to the allegation made in the complaint.
b) It is the test report issued by the GA opining that the drug/batch is NSQ at a subsequent date is the basis of presumption that the drug/batch must have been NSQ when manufactured and sold/distributed.
c) Hon’ble Supreme Court of India in the matter between State of Rajasthan Vs Sanjay Kumar and Ors, (DC 1998, SC, 7) in Para 9 observed as
“On the date of collection of samples from respondent no. 16, on Feb. 29, 1988, it could not have been said that any offence was committed as selling of drugs per se is no offence and the quality of drugs was not known to the Drugs Inspector, the complainant on that date. It is only when the report of the Government Analyst was received, it came to the light that the provisions of the Act are violated and offence is committed.”
d) Allegation of contravention of s.18 (a) (i) seeking punishment u/s 27(d) of the ‘Act’ could be possible only if:-
i) There is documentary evidence that at the time of release of drug/batch for sale/distribution and based on manufacturing and testing record the drug was in fact Not of Standard Quality (NSQ) at that itself.
There is not a single known example where allegation of violation of sec. 18(a) (i) is levied with aforesaid or any similar documentary evidence with the complaint or otherwise.
The Drugs Inspector and all other superior officials in the Regulatory in the Centre and States, baring exceptions, are claiming to be qualified and experienced in the profession and therefore, in appropriate cases investigation on above technical aspect is definitely expected. Such officials are not supposed to act as ‘Bada Babu’ and ‘Babu’.
ii) The manufacturer-licencee continues sale/distribution of disputed drug even after receipt of adverse test report. Almost in each and every case no unsold stock of the disputed drug is available with the manufacturer-licencee, at the time when such adverse test report is received by it, therefore, question of sale/distribution of disputed drug after receipt of adverse test report does not arise and any allegation to that effect is unlawful and unfounded.
On the contrary in 100% cases, the manufacturer-licencee, on being directed, as provided u/r 74(j), 78(i) by the State Licensing Authority, initiates effective steps to recall stocks of disputed drug/batch, as for as practical, from the market/institutions to whom the said drug was sold. The manufacturer-licencee is also required to intimate SLA of the quantity, if any, received back from the market and ensure its due destruction in presence of FDA official.
e) The object of sec. 18(a) (i) also aims at dealers/institutions etc. who if ignore the intimation about adverse test report received either from the DI or manufacturer-licencee and continue the sale/distribution etc. of the disputed drug/batch. In such circumstances and if due investigation is carried out only such dealers/institutions are liable to be prosecuted.
f) There is no provision in sec. 27 to punish any body even if a drug/batch is found NSQ, except as described above, and except as provided u/s 27 (a), if attracted, the relevant portion is abstracted here below:
“Solely on account of such drug being adulterated or spurious or not of standard quality, as the case may be”
Which means any drug if is likely to cause death or is likely to cause such harm on the body as would amount to grievous hurt within the meaning of sec. 320 of Indian Penal Code solely on account of such drug being not of standard quality, is punishable. Sub-sections (b) and (c) of sec. 27 are not relevant to this article.
Sub-section (d) of sec. 27 being residual section is invariably applied seeking punishment for violation of sec. 18(a) (i) particularly for drug reported NSQ. This section provides punishment for any drug, other than a drug refered to clause (a) or clause (b) or clause (c) in contravention of any other provision of this chapter or any rule made there under.
Now if we relook at sec. 18(a) (i) which is prohibitory provision and as demonstrated above, there is hardly any evidence in support of allegation that the drug/batch when manufactured and sold was NSQ at that stage only; seeking of punishment u/s 27(d) is absolutely irrelevant. In other words sec. 27(d) does not prescribe any punishment even if drug/batch is reported NSQ unless and until prohibitory provision of sec. 18(a) (i) is contravened.
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There is yet another land mark judgment reported in 2010(1) Drugs Cases 277, Allahabad, DB, (Brahmaji Vs State of U.P. & Ors). High Court issued the following directions:
(i) that the Central Government and the State Government will both give a clear indication as to how they plan to take effective action for controlling menace of spurious drugs;
(ii) the State Government to ensure within two months all the requisite manpower and required infrastructure, i.e. creating adequate number of laboratories etc;
(iii) both the Central Government and State Government to inform this Court as to what strategy they propose to adopt so that focused raids are conducted and samples taken so that effective measures can be made for identifying the manufacturers or dealers in spurious drugs;
(iv) the State Government to inform the Court about the time frame in which the computerization system of which the plan has been submitted by the NIC will be operational.
Note: U.P. has 71 districts, 53 Drugs inspectors, 400 manufacturing units, 180 blood banks, 50000 retail and 40000 wholesale outlets.
The provisions of Drugs and Cosmetics Act 1940 and Rules 1945 made there under are nicely designed, except the latest amendment of 2009, but these are being misinterpreted, misguided, misused, wrongly targeted, abuse of powers vested in so-called Experts in department of Drug Control whether Central or State. It is very convenient to demonstrate with evidence that these officials are involved in activities against the provisions of the ‘Act’ and ‘Rules’. They are least interested to safe guard public health even on written complaints with evidence, they prefer to negotiate with the erring person(s) and keep shut.
Such officials in majority cases are badly infected with C.Coli (Corrupto Coli) and could be for the time being be treated with veterinary dose of M.cillin Tabs. 10000 mg S.O.S.
Therefore it is rightly said ‘POWER CORRUPTS AND ABSOLUTE POWER CORRUPTS ABSOLUTELY.
The author dare say that the pharma SMEs in majority cases has been the victim of GANG RAPE by the (un)qualified, (un)trained and (un)skilled regulatory and Lab. Officials, Political leadership, Top bureaucrats and MNCs/LSI in the country. Exceptions are always there.
Look how the Pharma SMEs became victim of GANG RAPE
1. MNCs and Large Scale Industry was given FREE hand to market Generic Drugs in the country- who gave tough competition to SSI
2. National / State procurement Agencies included eligibility criteria in their tenders for purchase of medicines like
(a) Annual Turn Over of ranging from 5 to 50 crs.
(b) Possession of WHO/DGQA certificate for product(s) being offered;
(c) Minimum three years experience of manufacturing and marketing of product(s) being quoted. and
(d) Earnest Money Deposit in cash to tune of lakhs of rupees.
3. Creation of TAX FREE ZONES
4. Notification of Revised Schedule M
5. Excise Duty on MRP
6. Criminal Prosecutions on false, baseless grounds and without any investigation, under the ‘Act’ and ‘Rules’ at other than manufacturing State.
7. Notification of Drugs and Cosmetics (Amendment) Act 2008 (Commonly known as Spurious Drugs Act)
8. Notification of Good Laboratory Practices.
Thus the number of Industry of modern medicines which was 20000+ in the year 2000 is reduced to 10000 in the year 2007 as per Government data. BUT actually data as on date is not more than 5000 actually functioning. Where 80% business share goes to 20% MNCs/LSI and 20% business to 80% SMEs.
SUGGESSTION:
The only suggestion that the Government should take over willing SMEs in the country, paying them market value of their industrial assets and run those industries as government enterprises. If this is implemented all the problems shall be solved in one stroke.
Let us have faith that right makes might, and in that faith, let us, to the end, dare to do our duty as we understand it……Abraham Lincoln
If you have ten thousand regulations, you destroy all respect for the law.
Winston Churchill
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