Through this writ petition, the petitioner has called in question the tests reports of the Drug Testing Laboratory, Punjab and National Institute of Health, Islamabad, declaring the samples of Tincture Benzoin Co. Supplied by the petitioner to the Health Department of the Punjab Government as substandard and the decisions of the Provincial Quality Control Board, Punjab, contained in their letter dated.1-9-2001. The facts relevant for disposal of this writ petition are as follows:
2. The petitioner is a manufacturer of drugs under a licence issued in its favour under the provisions of the drugs Act, 1976. In response to a tender notice, the petitioner supplied 19776 bottles of 450 MI each of Tincture Benzoin Co. To the Government of the Punjab. According to the terms of the work order the consignment was subject to inspection and tests of all samples and the supply was to be governed by Drugs Act, 1976.
3. On 1-1-2001 eight samples were taken from all the eight batches. These were tested by the Drug Testing Laboratory, Punjab and vide separate reports dated 28-2-2001 all the samples were declared as substandard.
4. The petitioner challenged the aforesaid reports of the Drug Testing Laboratory in a representation dated 14-4-2001 addressed to the Provincial Drug Inspector and a representation dated 16-4-2001 filed before the Chairman, Provincial Quality Control Board, Punjab. These samples were referred to the National Institute of Health, Islamabad, and according to their reports dated 12-6-2001 all the samples were declared as substandard..
5. Based on the reports of the Drug Testing Laboratory, Punjab and the National Institute of Health, Islamabad, notice dated 25-6-2001 was . Addressed to the petitioner, its Managing Director, the Quality Control Incharge and the Warrantor to show cause against prosecution, other legal action and recommendation to the Central Licensing Board for cancellation or suspension of petitioner's drug manufacturing licence. According to the averments of the petitioner, the petitioner appeared before the Quality Control Board through its counsel on 1-9-2001. However, impugned letter dated 1-9-2001, shows that the Provincial Quality Control Board in its meeting held on 25-8-2001, decided to prosecute the above persons, directed destruction of the stocks of substandard drug lying in Medical Store Depot and called upon the petitioner to supply fresh stocks as per contractual obligations.
6. The learned counsel for the petitioner contends that the test reports of the two laboratories were not in accordance with rule 16 of the Drugs (Federal Inspectors, Federal Drug Laboratory and Federal Government Analysts) Rules, 1976 inasmuch as that the reports did not contain the "full protocols" of the test applied. He maintained that in the said reports only the conclusions were recorded but the manner and the method by which the conclusions were arrived at was not indicated in the said reports. He maintains that provisions of rule 16 aforesaid are mandatory and a breach thereof entails vitiating consequence. Reliance was placed on Gyanendra Nath Mittal v.
State (AIR 1959 Allahabad 634), S.Dutta and another v. The State (AIR 1959 Calcatta 427); Dharam Deo Gupta v. State AIR 1958 Allahabad 865). It was next contended that opinion of an' expert must be supported by adequate factual data so that if it is challenged before a Court of law, the validity thereof could be ascertained. He maintains that the reports of the Provincial Drug Testing Laboratory and the National Institute of Health were at variance and the deficiencies pointed out in the reports could be made up by supplying the deficient ingredients. He therefore, maintained that if the Government of the Punjab was willing to return the consignment to the petitioner, he will remove the deficiencies. Such a course, according to him was permissible, by virtue of rule 15(4) and (5) of the Drugs (Import and Export) Rules, 1976. It was further contended that the Provincial Quality Control Board could not in any case direct destruction of the drugs and it was only within the jurisdiction of the Drug Court, under section 29 of the Drugs Act, and that too only after recording the conviction under the Drugs Act, 1976.
7. The learned Additional Advocate-General, on the other hand,.Submits that not only the Provincial Drug Laboratory the National Institute of Health have found the drug supplied by the petitioner as substandard for which he is being prosecuted, it will be for the trial Court to determine the controversy and, therefore no interference is called for.
8. Dr. Muhammad Asghar, Scientific Officer, Drug Control and Traditional Medicine Division, National Institute of Health, Islamabad is in attendance. According to him, the tests in relation to the samples of eight batches were carried out under the British Pharmaceutical Code, 1973 and according to him complete protocols were followed. Therefore, the requirement of rule 16 was duly complied with.
9. I have considered the submissions made by the learned counsel for the parties. While a sample is drawn under section 19 of the Drugs Act, 1976 it is analyzed by a Government Analyst under section 22 of the Drugs Act. Under subsection (4) of section 22 this report is admissible in evidence without formal proof and is conclusive unless the person from whom the sample was taken challenges it within 30 days of the receipt of the copy of the report of the Government Analyst under section 22 (5) of the said Act.Once the report of the Government Analyst is challenged the Drug Court or the Quality Control Board concerned any of its own motion or on the request of the complainant or accused forward the sample to the Federal Drug Testing Laboratory or any Laboratory specified for the purpose by the Federal Government who shall make test or analysis and report in writing the result thereof which is also declared as conclusive evidence of the facts stated therein. Pursuant to section 43 of the Drugs Act, 1976 the Drugs (Federal Inspectors, Federal Drug Laboratory and Federal Government Analysts) Rules, 1976 were framed. Rule 16 thereof, which is required to be - interpreted, is reproduced hereunder for facility of reference: "16. Report of result of test or analysis.--(1) After test of analysis the result thereof together with full protocols of the test applied, shall be supplied forthwith to the sender in Form 6. (Emphasis supplied).
(2) The Government Analyst shall, for the purpose of subsection (1) of section 22, forward a copy of the report to the Registration Board in the case of a registered drug and to the Central Licensing Board in all other cases.
(3) For the purpose of subsection (2) of section 22, the further period within which the report should be made available to the Inspector shall be sixty days."
10. Perusal of section 16 of the aforesaid Act shows that while the Federal Drug Testing Laboratory is bound to record the full protocols of the test applied there is no such requirement while testing, or analysing a sample under section 22(1) of the Drugs Act. The Federal Drugs Laboratory is charged with the function to carry out tests and analysis of samples of drugs sent to it under subsection (5) of section 22 of the Drugs Act or the samples sent to it by the Federal Government or to carry out other functions as may be entrusted to it by the Federal Government or with the prior approval of the Federal Government by a Provincial Government. I am therefore, of the view that rule 16 aforementioned only applies to the test and analysis done by the Federal Drug Testing Laboratory.
Therefore what is required to be examined is whether the reports of the National Institute of Health met the requirement of rule 16 aforesaid. The expression "protocols of test" has not been defined in the Drugs Act or the Rules framed there under. However, definition of "protocol" as given in the Black's Law Dictionary (Sixth Edition) is as follows:-- " 'Protocol'. A brief summary of the .Text document. Also, the minutes of a meeting which are generally initiated by the parties present to reflect their assent to the accuracy of the minutes. A section of the Department of State charged with the preparation of agreements and treatises.
Commonly, term refers to the etiquette of diplomacy and the ranking of officials."
11. In the case of Gyanendra Nath Mittal (supra) the learned Allahabad High Court, while interpreting rule 46 of the United Provinces Drugs Rules, 1945 which is in para materia with rule 16 aforesaid, observed that "the Government Analysts had simply stated the result of the test but has not given the protocols at all. He has not mentioned what tests were applied and, therefore, the result is not in the prescribed form. When it is not in the prescribed 'form it cannot be conclusive evidence of the facts stated therein". It was further observed that failure to given protocols is a fatal defect.
12. The expression "full protocol of the tests applied" also came under consideration of the Calcutta High Court in S. Dutta and others and the following observations were recorded by the said learned Court:--
7. Result of test or analysis with protocols of tests applied. It is thus clear that a Government Analyst has to submit a report in Form I of the result of the test or analysis concerned together with full protocols of the tests applied. Unless full protocols of tests are supplied, the report of a Government Analyst cannot be regarded as conclusive evidence, or indeed as any evidence, of the facts stated therein. This position is not challenged on behalf of the State. What was argued on behalf of the State was that the relative certificate (Exh.35) contained full protocols of the tests applied by the Government Analyst. Mr. J.N. Banerjee on behalf of the State was, however, not clear as to the meaning of the word 'protocols' and there was no evidence as to what was meant by the word.
Accordingly, we examined the Government Analyst Mr.P.K. Sanyal, to tell us what he meant by the expression "full protocols of the tests applied'. We discovered, to our amazement that the Government Analysts had been approached on behalf of the prosecution and forewarned as to the point which troubled us. There is no doubt that the word 'protocol' or 'protocols' has been and is now used in different senses. Originally, the word appears to have meant the original note or minute of a transaction, negotiation agreement or the like, drawn up by a recognized public official, notary etc. And duly attested, which forms the legal authority for any subsequent deed. Agreement, or the like based on it. The word 'protocol' meant as it does now, a formal or official statement of a transaction or proceeding. Mr. Dutta urged that the word used in the drugs rules meant the original minute or report of the tests applied in the case, especially -in view of the fact that by subsection
(3) of section 25 of the Act the report of a Government Analyst was made conclusive evidence or the facts stated in it. In our view, the expression 'full protocols of tests applied' means an official statement or account of a proceeding as a description of an experiment or a clinical report. Indeed this is one of the meanings of the word 'protocol' or 'protocols' given in Webster's Dictionary, volume II, 1934 Edition." After recording the above observation the learned Calcutta High Court found that various tests employed by the Analyst were in fact embodied in the report itself. In the case of Dharam Dea Gupta (supra), which also arose out of a criminal prosecution, the learned Allahabad High. Court recorded the following observations:
(22) The Drugi Act contains prescribed forms and Form 2 framed under Rule 6 of the Drugs Rules, 1945, clearly mentions the requirements which a certificate of test or analysis by the Central Drugs Laboratory should contain. It is mentioned in this form which is Form 2 in Schedule A that details of result of tests or analysis with protocols of tests applied should be given. Exh.P.10 contains no such details. As a matter of fact it contains no factual data at all. The reason is not far to seek. This report was not given for the purpose for which the prosecution is utilizing it. If the Central Drugs Laboratory had known that they were to give a report for the purposes of prosecuting the accused person under the Drugs Act, they would have given this data. A report which does not contain any factual data cannot be treated as conclusive evidence of the opinion given in the report." It was further observed: "(25) It may also be kept in mind that the reasonable possibility of an error being committed by the Government Analyst when he is analysing or testing a sample cannot be eliminated. The Court has a right to satisfy itself that the chance of a mistake has been eliminated. It can do so if sufficient factual data is given in the report. This factual data by itself will show that the opinion given is fully borne out. But where the opinion is not supported by any faxtual data, the Court cannot test the opinion of the Government Analyst and can only accept it in a blind manner. The liberty of the people cannot be taken away from them on such evidence which cannot be tested. It is, therefore, necessary that the procedure laid down in the Drugs Act is strictly followed and where this procedure has not been followed the report of the Government Analyst cannot be treated as conclusive evidence."
13. Although aforesaid cases arose out of criminal prosecution, yet the rule clearly laid down is that the report of the Analyst to be conclusive, must disclose the tests applied therefor and administrative body cannot act on such a report which is not in accordance .With law. The rule- making authority while insisting that the report should contain "full protocols of the test applied" clearly contemplated that it should be self-contained so that its authenticity could be tested if it is disputed.. Since the report of the Federal Drug Testing Laboratory being conclusive' entailed serious consequences of not only jeopardizing liberty of a person and depriving him of his source of livelihood, the provision of rule 16 has to be strictly construed even though the said provision was procedural yet the result of the tests affects substantial rights of a person. I am, therefore, of the view that provision of rule 16 aforesaid is mandatory. It may also be observed that when law requires a particular thing to be done in a particular manner, it can only be done in the said manner and in no other particularly when it may affect and of the rights of a person.
14. The report and the certificate of the National Institute of Health in case of the sample relating to Batch No,617 are reproduced hereunder for facility of reference: DETAILS OF RESULT OF TEST OR ANALYSIS (with protocols of test applied)
TEST REPORT NO.037-P/2001 Nomenclature: Tincture Benzoin Co.
Batch No, 617 Date of Manu. 12-2000 Date of Expiry 12-2002 Manufacturer Nawabsons Laboratories (Pvt.) Ltd., Lahore Description: Yellowish brown liquid in white plastic bottle having sedimenterl mass which remains uridisiolvedreri on shaking. Does not comply with BTC.73.
Identification: Alcohol and Balsamic acid identified.
WT/ML: Determined: 0.871 gm/ml Limit: 0.890-0.910 gm/ml Does not comply with BPC.73.
Total Solids: Determined: 9.04% w/v Limit: 15-19% w/v. Does not comply with BPC.73 Assay: Found Limit. 4.74% w/v Not less than 4.5% w/yv complies with BPC.73.5.
Alcohol: 57.285% w/v 70-76% v/v does not comply with BPC.73.
CONCLUSION:The sample is of substandard qualityon the basis of tests performed.
Form-6.
(See Rule -16)
CERTIFICATE OF TEST OR ANALYSIS BY THE DRUGS CONTROL AND TRADITIONAL MEDICINES DIVISION NATIONAL INSTITUTE OF HEALTH. ISLAMABAD Certified that the sample(s) bearing number R.34-3/2001 purporting to be a sample of TINCTURE BENZOIN CO. Received on 24-4-2001 from The Secretary. Provincial Quality Control Board, Punjab.
Lahore vide Office Memo. No,PQCB/R.33-3/2001 to 40-3/2001 dated 21-4-2001 has been tested/analysed and that the result of such test/analysis is stated below:-- Description: Yellowish brown liquid in white plastic bottle having sedimented mass which remains dissolved even on shaking. Does not comply with BPC 73.
Identification: WT/MLAlcohol and Balsamic Acid identified. Determined: 0.871 gm/ml limit: 0.890-0.910 gm/ml Total Solids: Does not comply with BPC 73. Determined 9.04% w/v Limit: 15-195 w/v Does not comply with BPC 73.
Assay: FOUND LIMIT Balsamic Acid 4.74% Not less than 4.5% Complies with BPC 73.
Alcohol: 57.285% V/V 70-76%V/V The condition of seal on the packet on receipt was as follows: Satisfactory. In the opinion of the undersigned the sample is substandard as defined in the Drugs Act, 1976 for the reason(s) given below:-- Description: Yellowish brown liquid in white plastic bottle having sedimented mass which remains undissolved even on shaking. Does not comply with BPC.
WT/NML Determined: 0.871 gm/ml Limit: 0.890-0.910 gm/ml Does not comply with BPC 73 Total Solids: Determined 9.04% w/v Limit: 15-19/% w/v Assay: FOUND LIMIT Alcohol: 57,285%v/v 70-76% v/v Does not comply with BPC 73 (Sd.)
ACTING CHIEF, Drugs Control and Traditional Medicines Division, National Institute of Health, Islamabad, or Authorised Officer/ Government Analyst.
15. The reports in respect of the samples relating to Batches Nos.618, 620 and 624 are the same.
However, in case of samples pertaining to Batches No,19, 621, 622 and 625 the contents of balsamic acid were also found to be deficient. A perusal of the test report and the certificate shows that the officer concerned of the National Institute of Health had only recorded his conclusion that the samples did not comply with BPC-73 (British Pharmaceutical Code, 1973) on the basis of the tests performed without giving the necessary details to what tests were applied to reach the aforesaid conclusion. A perusal of the British Pharmaceutical Code, 1973 shows that not only it prescribes the standards as to the contents of a drug but also the methods be applied to test a drug and the method applied was required to be given in the said report. The report and the certificate of the National Institute of Health, reproduced above, does not at all indicate the method applied to arrive at the conclusion that the drug supplied by the petitioner was substandard, although the report professed that full protocol of tests were applied. The report and the certificate of the National Institute of Health not being in accordance with law, could not have formed basis of the decisions of the Provincial Quality Board, Punjab contained in the letter dated 1-9-2001.
16. There is merit in the contention of the learned counsel for the petitioner that a direction for destruction of the drugs could not have been issued by the Provincial Quality Control Board, it could only be rendered by the Drug Court on conviction of an offender as provided by section 29 of the Drugs Act, 1976 read with rule 9 of the Drugs (Federal Inspectors, Federal Drug Laboratory and Federal Government Analysts) Rules, 1976. However, since I have reached the conclusion that the report of the National Institute of Health did not meet the requirement of rule 16, further examination of this question is not necessary.
17. For what has been stated above, this writ petition is allowed and the impugned reports of the National Institute of Health dated 12-6-2001 and the decisions contained in the letter dated 1-9- 2001 of the Provincial Quality Control Board, Punjab are declared as without lawful authority and of no legal effect. The date of expiry of the drugs is December, 2002, it is therefore, directed, that fresh samples will be taken in accordance with law and sent to the National Institute of Health for fresh test and analysis and the said Institute shall test and analyse the samples and submit a report with "full protocols of the test applied" in accordance with rule 16 of Drugs (Federal Inspectors, Federal Drugs Laboratory and Federal Government Analysts) Rules, 1976, and respondents 1 and 2 may then proceed in the matter in accordance with law. No order as to costs.