| Jagmohan Rai Agarwal |
The scope of this article is limited to this 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 Drugs 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 is “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 the law
Laws regarding qualifications of government analysts and drugs inspectors, licensing authority and controlling authority are as follows:
Government analyst: Graduate/ Post graduate in Medicine or Science 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 specialisation 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 specialisation 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 specialisation 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 note that none of the 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 on 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.
It is also an irony that in a few states the head of FDA does not meet qualification/experience prescribed and such officials are fully involved in enforcement of the Act/Rules.
State government testing laboratories, central drug laboratory
It is an undisputed fact that in India, test reports issued by Government Analyst(s) whether belonging to state laboratory 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 seven were reasonably equipped / staffed, while the others were poorly staffed and did not even have the bare minimum equipment. (Page 2 of the report).
2. The limitations in testing of drug samples in the government laboratories 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 of the report).
Other issues
(i) None of these government laboratories, including the CDL, have ever been audited, forget audited at regular intervals.
(ii) There is no arrangement for training at regular intervals 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 equipment and trained expert technical staff to handle those equipment.
The entire ‘Act’ has been prepared for the purpose of proper enforcement of the Drugs and Cosmetics Act. Also we find that it is the drug 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 a 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 Rs 10,000;
(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 Rs 5,000:
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 Rs 5,000;
(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 Rs 5,000:
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.
S. 27 is further amended vide Drugs and Cosmetics (Amendment) Act 2008 notified on August 10, 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 Rs 10 lakh 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 referred to in this clause:
Provided further that where the use of the adulterated or spurious drugs referred 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 referred 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 Rs one lakh 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 Rs one lakh);
(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 Rs 20,000):
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 recognised 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 authorised 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 May 8 2012
(viii) CDTL, Hyderabad is yet to be equipped, and other five CDL/CDTL at Calcutta, Mumbai, Chennai, Guwahati and Chandigarh were reasonably equipped but not fully equipped and required upgradation with the state-of-the-art facilities for testing/analysing 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)
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 Government Analyst while adopting IP without mentioning the year of the edition. Prosecution launched by the DI in the sampling State in the year 2003. 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 Government 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 one can imagine the scenario of the Government 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’ 125mg/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, forget taking action against the defaulting manufacturer.
There are innumerable numbers of such case studies where industries belonging to SME sector are facing the music. During one of the high level committee meetings conveyed by the then Health Minister Madhya Pradesh in the year 1987 attended by top bureaucrats in the Ministry along with delegation of MP Pharmaceutical Manufacturers Organisation, Indore lead by the author, the then President of the Association, OP Dubey, I.A.S. the then Drugs Controller, MP had made a statement saying that 98 per cent of the prosecution cases launched in the state prior to his taking charge are unwarranted.
(The author can be contacted at sharda_jollo@yahoo.co.in)