Richardson Hindustan Limited and anr. Vs. State of Rajasthan and ors. - Court Judgment

Excerpt:
- - 3 in relation to amrutanjan a pain balm wherein it has been clearly mentioned that this drug has been manufactured at certain place. 2 is perfectly valid and it is up to the petitioner-company either to comply with the provisions of the act and the rules or to face the consequences of the same.orderj.c. verma, j.1. the petitioner no. 1 m/s. richardson hindustan ltd. (referred to hereinafter as 'the petitioner-company') is a private company registered under the provisions of the companies act and is engaged inter alia in the business of manufacturing ayurvedic medicines and drugs. the second petitioner is a shareholder of the petitioner-company and is also an officer of the petitioner-company. it is stated that the petitioner-company has two factories, one at kalwi, thana district, maharashtra and the other at annaram in medak district andhra pradesh, where they manufacture an ayurvedic medicine known as vicks vaporub and holds licences for manufacture of the said vicks vaporub. vicks vaporub is a product of ayurvedic medicine being manufactured by the petitioner-company. the petitioner-company under the law i.e. the drugs and cosmetics act, 1940 (referred to hereinafter as 'the act') and the rules framed thereunder is supposed to comply with the statutory provisions in regard to the labelling of ayurvedic drugs. sub-rule (3) of rule 161 states that the particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any ayurvedic drug and on any other covering in which the container is packed. the label should contain the name and address of the manufacturer. it is stated that even though the word 'manufacturer' is not defined in the act, therefore, the meaning of the manufacturer should be taken which is accepted in the common parlance i.e. a person who produces an article or who is responsible for manufacture. it is admitted that the petitioner-company is a manufacturer of the product mentioned above.2. it is stated that on 26-11-1986 the non-petitioner no. 2 i.e. the drugs inspector (ayurveda), udaipur visited the shop premises of one of the petitioner-company's dealers in udaipur, namely, m/s. jai medicals at 62, mandi-ki-nal. udaipur and examined the bottles of vicks vaporub being sold there. a note had been given by the drugs inspector that the address of the manufacturer has not been provided on the label but the address of the registered office has been mentioned. the inspection note is attached as annex. 4 to the writ petition. the petitioner-company was informed by the dealer m/s. jai medicals of the note incorporated by the drugs inspector, respondent no. 2 vide letter dated 1-12-1986, a copy of which is attached as annex.5 to the writ petition. it is stated that the petitioner company had narrated the facts and informed the respondent no. 2 vide their letter annex.6 which is said to have been personally delivered in the office of the respondent no. 2 in the month of december, 1986. it is alleged that the officers of the petitioner-company had visited udaipur on 6-5-1986 and they were given threates by the respondent no. 2 that their material would be seized in case the top management of the petitioner-company did not come out personally and satisfy him about the compliance of the rule 161(3)(iii). it is the case of the petitioner-company that in the market number of drugs are being sold where instead of showing the place of manufacturing of the drugs the address of registered office has been mentioned. it is submitted that the prevalent practice in the market is to give out the address of the registered office of the manufacturer and not of the factory and it is for the first time that an exception is being taken in the case of the petitioner-company. the petitioner-company is apprehensive of the fact that the non-petitioner no. 2 is likely to take action against the petitioner on the ground of misbranded ayurvedic drug and further submits that from the printing of the label itself it is very clear that no rule has been violated.3. the petitioners have prayed to issue a writ of prohibition against the respondents restraining them from seizing and detaining vicks vaporub or any of the ayurvedic drugs manufactured by the petitioner-company on the ground that the labels of the same do not mention the address of the manufacturing place of the said drugs, vicks vaporub.4. a reply has been filed on behalf of the respondents. the facts as stated above are not denied. it is reiterated in the written statement that under the provisions of the act and the rules framed under the drugs and cosmetics act, 1940 the particulars of the manufacturer are required to be printed or written in indelible ink which should appear in a conspicuous manner on the label of the innermost container of any ayurvedic drug and a reference has also been made/ invited in regard to certain instructions that the printing of complete address of the manufacturing place on the label/carton of the products is to be mentioned. it has further been mentioned that the provisions of the act shall be in addition to and not in derogation of dangerous drugs act, 1930. it is submitted that the word manufacturer has been defined as any person who manufactures a drug and includes any process or part of a process for making, altering, ornamenting, finishing, packing, labelling, breaking up or otherwise treating or adopting any drug with a view to its sale or distribution. a further objection has been taken that the petitioner ought to have filed an appeal under rule 159 of the rules of 1945. it is denied that other drug i.e. amrutanjan has not mentioned the place of production. it is also denied that any drug has been seized. it is stated that the drug has been freezed for a period of 20 days with intimation to the higher ups for necessary action as per annex.r.4.5. vide the notice dated 12-8-1985 attached as annex. r.1 all the drugs inspectors were directed to see that the compliance of rule 96(1)(iv) of the drugs and cosmetics rules, 1945 requiring to display the name and address of the manufacturer on the label and covering of a drug in a conspicuous manner be observed. the respondents have also attached annex.r.3 in relation to amrutanjan a pain balm wherein it has been clearly mentioned that this drug has been manufactured at certain place.6. the only question which requires to be determined is whether under the provisions of rule 161 of the rules framed under the act, is it essential, mandatory and statutory obligation for the petitioner company to mention the address? for this purpose reproduction of rule 161 shall be essential. rule 161 of the rules reads as under:--'161. manner of labelling.-- (1) there shall be conspicuously displayed on the label of the container or package of an ayurvedic (including siddha) or unani drug, the true list of all the ingredients used in the manufacture of the preparation together with the quantity of each of the ingredients incorporated therein and a reference to the method of preparation thereof as detailed in the standard text and adhikarana, as are prescribed in the authoritative books specified in the first schedule of the act:provided that if the list of ingredients contained in the medicine is large and cannot be accommodated on the label, the same may be printed separately and enclosed with the packing and reference be made to this effect on the label.(2) .....(3) subject to the other provisions of these rules, the following particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any ayurvedic (including siddha) or unani drug and on any other covering in which the container is packed, namely:-- (i) and (ii) .....(iii) the name and address of the manufacturer. 7. the counsel for the parties have not been able to cite any authority on the point, but it is submitted by the counsel for the petitioner that the name and address as required to be indicated on the label will also meet the interest of justice, if the name and place of the registered office is given. the rationale behind providing such a rule is, according to my opinion, that the manufacturer is supposed to mention the name and address of the manufacturer and the address of the manufacturer in the present case shall be the place where the drug is manufactured. the idea for providing the name and address of the manufacturer is for the purpose that in tease any defect is found in the drug, the officer-in-charge or the controlling authority appointed under the act can straightway inspect the place of manufacturer and that should be the address and not the registered office. in case the petitioner-company for its own convenience wants to mention the place of the registered office, if may do so but it is essential for the petitioner-company to mention on the label the name and place where the material is manufactured with its address and not the address of the registered head office. in case the petitioner-company wants to mention the address of the registered office, it may do so in addition to the earlier fact of mentioning the place of manufacture i.e. where the drug is actually manufactured. the notice issued by the respondent no. 2 is perfectly valid and it is up to the petitioner-company either to comply with the provisions of the act and the rules or to face the consequences of the same. no illegality can be found in the notice issued by the drugs inspector which seems to have been rightly issued for violation of rule 161 (3)(iii) of the rules framed under the drugs and cosmetics act, 1940 i.e. drugs and cosmetics rules, 1945.8. the writ petition has no merit and therefore, the same is dismissed. no order as to costs.

Judgment:
ORDER

J.C. Verma, J.

1. The petitioner No. 1 M/s. Richardson Hindustan Ltd. (referred to hereinafter as 'the petitioner-company') is a private company registered under the provisions of the Companies Act and is engaged inter alia in the business of manufacturing Ayurvedic medicines and drugs. The second petitioner is a shareholder of the petitioner-company and is also an officer of the petitioner-company. It is stated that the petitioner-company has two factories, one at Kalwi, Thana District, Maharashtra and the other at Annaram in Medak District Andhra Pradesh, where they manufacture an Ayurvedic medicine known as Vicks Vaporub and holds licences for manufacture of the said Vicks Vaporub. Vicks Vaporub is a product of Ayurvedic medicine being manufactured by the petitioner-company. The petitioner-company under the law i.e. the Drugs and Cosmetics Act, 1940 (referred to hereinafter as 'the Act') and the rules framed thereunder is supposed to comply with the statutory provisions in regard to the labelling of Ayurvedic drugs. Sub-rule (3) of Rule 161 states that the particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any Ayurvedic drug and on any other covering in which the container is packed. The label should contain the name and address of the manufacturer. It is stated that even though the word 'manufacturer' is not defined in the Act, therefore, the meaning of the manufacturer should be taken which is accepted in the common parlance i.e. a person who produces an article or who is responsible for manufacture. It is admitted that the petitioner-company is a manufacturer of the product mentioned above.

2. It is stated that on 26-11-1986 the non-petitioner No. 2 i.e. the Drugs Inspector (Ayurveda), Udaipur visited the shop premises of one of the petitioner-company's dealers in Udaipur, namely, M/s. Jai Medicals at 62, Mandi-ki-Nal. Udaipur and examined the bottles of Vicks Vaporub being sold there. A note had been given by the Drugs Inspector that the address of the manufacturer has not been provided on the label but the address of the registered office has been mentioned. The inspection note is attached as Annex. 4 to the writ petition. The petitioner-company was informed by the dealer M/s. Jai Medicals of the note incorporated by the Drugs Inspector, respondent No. 2 vide letter dated 1-12-1986, a copy of which is attached as Annex.5 to the writ petition. It is stated that the petitioner company had narrated the facts and informed the respondent No. 2 vide their letter Annex.6 which is said to have been personally delivered in the office of the respondent No. 2 in the month of December, 1986. It is alleged that the officers of the petitioner-company had visited Udaipur on 6-5-1986 and they were given threates by the respondent No. 2 that their material would be seized in case the top management of the petitioner-company did not come out personally and satisfy him about the compliance of the Rule 161(3)(iii). It is the case of the petitioner-company that in the market number of drugs are being sold where instead of showing the place of manufacturing of the drugs the address of registered office has been mentioned. It is submitted that the prevalent practice in the market is to give out the address of the registered office of the manufacturer and not of the factory and it is for the first time that an exception is being taken in the case of the petitioner-company. The petitioner-company is apprehensive of the fact that the non-petitioner No. 2 is likely to take action against the petitioner on the ground of misbranded Ayurvedic drug and further submits that from the printing of the label itself it is very clear that no rule has been violated.

3. The petitioners have prayed to issue a writ of prohibition against the respondents restraining them from seizing and detaining Vicks Vaporub or any of the Ayurvedic drugs manufactured by the petitioner-company on the ground that the labels of the same do not mention the address of the manufacturing place of the said drugs, Vicks Vaporub.

4. A reply has been filed on behalf of the respondents. The facts as stated above are not denied. It is reiterated in the written statement that under the provisions of the Act and the rules framed under the Drugs and Cosmetics Act, 1940 the particulars of the manufacturer are required to be printed or written in indelible ink which should appear in a conspicuous manner on the label of the innermost container of any Ayurvedic drug and a reference has also been made/ invited in regard to certain instructions that the printing of complete address of the manufacturing place on the label/carton of the products is to be mentioned. It has further been mentioned that the provisions of the Act shall be in addition to and not in derogation of Dangerous Drugs Act, 1930. It is submitted that the word manufacturer has been defined as any person who manufactures a drug and includes any process or part of a process for making, altering, ornamenting, finishing, packing, labelling, breaking up or otherwise treating or adopting any drug with a view to its sale or distribution. A further objection has been taken that the petitioner ought to have filed an appeal under Rule 159 of the Rules of 1945. It is denied that other drug i.e. Amrutanjan has not mentioned the place of production. It is also denied that any drug has been seized. It is stated that the drug has been freezed for a period of 20 days with intimation to the higher ups for necessary action as per Annex.R.4.

5. Vide the notice dated 12-8-1985 attached as Annex. R.1 all the Drugs Inspectors were directed to see that the compliance of Rule 96(1)(iv) of the Drugs and Cosmetics Rules, 1945 requiring to display the name and address of the manufacturer on the label and covering of a drug in a conspicuous manner be observed. The respondents have also attached Annex.R.3 in relation to Amrutanjan a pain balm wherein it has been clearly mentioned that this drug has been manufactured at certain place.

6. The only question which requires to be determined is whether under the provisions of Rule 161 of the Rules framed under the Act, is it essential, mandatory and statutory obligation for the petitioner company to mention the address? For this purpose reproduction of Rule 161 shall be essential. Rule 161 of the Rules reads as under:--

'161. Manner of labelling.-- (1) There shall be conspicuously displayed on the label of the container or package of an Ayurvedic (including Siddha) or Unani drug, the true list of all the ingredients used in the manufacture of the preparation together with the quantity of each of the ingredients incorporated therein and a reference to the method of preparation thereof as detailed in the standard text and Adhikarana, as are prescribed in the authoritative books specified in the First Schedule of the Act:

Provided that if the list of ingredients contained in the medicine is large and cannot be accommodated on the label, the same may be printed separately and enclosed with the packing and reference be made to this effect on the label.

(2) .....

(3) Subject to the other provisions of these rules, the following particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any Ayurvedic (including Siddha) or Unani drug and on any other covering in which the container is packed, namely:--

(i) and (ii) .....

(iii) The name and address of the manufacturer.

7. The counsel for the parties have not been able to cite any authority on the point, but it is submitted by the counsel for the petitioner that the name and address as required to be indicated on the label will also meet the interest of justice, if the name and place of the registered office is given. The rationale behind providing such a rule is, according to my opinion, that the manufacturer is supposed to mention the name and address of the manufacturer and the address of the manufacturer in the present case shall be the place where the drug is manufactured. The idea for providing the name and address of the manufacturer is for the purpose that in tease any defect is found in the drug, the officer-in-charge or the controlling authority appointed under the Act can straightway inspect the place of manufacturer and that should be the address and not the registered office. In case the petitioner-company for its own convenience wants to mention the place of the registered office, if may do so but it is essential for the petitioner-company to mention on the label the name and place where the material is manufactured with its address and not the address of the registered head office. In case the petitioner-company wants to mention the address of the registered office, it may do so in addition to the earlier fact of mentioning the place of manufacture i.e. where the drug is actually manufactured. The notice issued by the respondent No. 2 is perfectly valid and it is up to the petitioner-company either to comply with the provisions of the Act and the rules or to face the consequences of the same. No illegality can be found in the notice issued by the Drugs Inspector which seems to have been rightly issued for violation of Rule 161 (3)(iii) of the Rules framed under the Drugs and Cosmetics Act, 1940 i.e. Drugs and Cosmetics Rules, 1945.

8. The writ petition has no merit and therefore, the same is dismissed. No Order as to costs.