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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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