That the Drug Controller acting as the Licensing Authority often passes order either refusing licenses or related to renewal of licenses. Cancellation of license is another tool which is resorted to by the Drug Controller. The cancellation of drug approval is yet another aspect which often gives rise to disputes between the licensee and Licensing Authority.

The provision relating to cancellation of license either in part or full or suspension of license is governed by Rule 85 (dealt by the author in this article) which relates to the manufacturing of Allopathic Drugs. Under the said rule the Licensing Authority has to give show cause notice and an opportunity to explain why order of cancellation or the suspension should not be passed? Such notice must be given in writing. If notice is issued and representation is received the Drug Controller will pass appropriate order. If the order of cancellation or suspension is passed by the drug controller and the licensee is not satisfied with the order and aggrieved by such order then under sub-rule 3 the licensee, within ninety days of the receipt of a copy of the order by him shall prefer an appeal to the Central Government or the State Government as may be applicable.

Thus The Drugs and Cosmetics Act, 1940, in itself has created the forum for appeal. If appeal lies to state or central government the process of domestic remedy has to be exhausted first before approaching the high court by writ. Normally the appeal in the state lies to the Principle Secretary of health department. In most of the states like Uttarakhand, Himachal, Punjab, Haryana, Jammu and Kashmir, Madhya Pradesh etc. has delegated power to the principle Secretary of Health. Under such circumstances, are the writs filed by the licensee against the order of Drug Controller or Licensing Authority before High Courts are valid without resorting to appeal provisions? The answer to the question in most of cases is NO, but this is subject to exception.

If a   statute has conferred   a power to   do an act   and has laid   down the method   in which that   power has to   be exercised, it necessarily   prohibits the doing   of the act   in any other   manner. The principle behind   the rule is   that if this   were not so, the   statutory provision might   as well not   have been enacted.

In Craies on Statute Law (7th Edn.), it is stated that the court will, as a general rule, presume that the appropriate remedy by common law or mandamus for action was intended to apply. General rule of law is that where a general obligation is created by statute and statutory remedy is provided for violation, statutory remedy is mandatory.


  1. In Firm Seth Radha Kishan vs. Administrator, Municipal Committee, Ludhiana, AIR 1963 SC 1547 : (1964)   2 SCR 273-Held   that if a   statute creates a   liability and gives   a special and   particular remedy for   the aggrieved party, the   remedy provided by it must   be followed. The same   principle would apply   if the statute   had provided for   a particular forum   for the remedy. Thus, in a case where   the liability is   created by a   statute, a party aggrieved   must pursue the   special remedy provided   by it and   he cannot pursue   his remedy in   a civil court.
  2. In Saraswati vs. Lachanna, (1994) 1 SCC 611 vide Para 7 observed that where a particular Act creates a right and also provides a forum for enforcement of such right and bars the jurisdiction of the civil court then ouster of the civil court jurisdiction has to be upheld.
  3. In Shiv Kumar Chadha vs. Municipal Corpn. of Delhi, (1993) 3 SCC 161 observed that that where   a statutory enactment   creates a right   or liability and   also provides a   forum for enforcement   of such right, the   ouster of the   civil court’s jurisdiction   can be upheld   on the finding   that the rights   or liabilities in   question have been   created by the   Act and the   remedy provided therein   is adequate and   complete. It has been also held that where a complete machinery for adjudication of all claims had been provided under an enactment and there being a bar on the jurisdiction of any court, the Act overrides other laws, including Section 9 of the Code of Civil Procedure and there was no scope for the civil court to entertain any suit.
  4. In Raymond Ltd. vs. State of Chhattisgarh, (2007) 3 SCC 79 It was observed vide Para 32 It is trite that no court can direct a matter to be governed by a statute other than that which is really applicable.
  5. Seth Chand Ratan vs. Pandit Durga Prasad, AIR 2003   SC 2736 : (2003) 5 SCC 399 in para 13 Hon’ble Supreme Court observed that It has been settled by a long catena of decisions that when a right or liability is created by a statute, which itself prescribes the remedy or procedure for enforcing the right or liability, resort must be had to that particular statutory remedy before seeking the discretionary remedy under Article 226 of the Constitution. When the party had statutory remedy of assailing the order passed by the District Court by filing an appeal to the High Court itself, he could not bypass the said remedy and take recourse to proceedings under Articles 226 and 227 of the Constitution. Such a course of action may enable a litigant to defeat the provisions of the statute.
  6. Mohan Singh vs. International Airport Authority of India, (1997) 9 SCC 132 under para 17 stated that where the language of statute creates a duty, the special remedy is prescribed for non-performance of the duty. General rule of law is that where a general obligation is created by statute and statutory remedy is provided for violation, statutory remedy is mandatory.
  7. Ramchandra Keshav Adke vs. Govind Joti Chavare, AIR 1975   SC 915 : (1975) 1 SCC 559 Para 25 SC held that the   rule adopted a century ago   in Taylor Taylor, (1876)   1 ChD 426, that where a power is given to do a certain thing in a certain way, the thing must be done in that way or not at all and that other methods of performance are necessarily forbidden, has stood the test of time. It was applied by the Privy Council, in Nazir Ahmad vs. King Emperor, AIR   1936 PC 253 (II)   and later by this Court in several cases.

Thus in ultimate analysis it is stated that the writ directly to the High Court against the order of the Drug Controller or Licensing Authority is not maintainable and it is necessary that the appeal remedy is exhausted.

While above preposition of the law is stated by the author, the view on opposite side is also known. It is not necessary that alternate remedy shall be exhausted before approaching in writ. Where there are special provisions of appeal, it will be necessary to go for appeal to the state government or central government as the case may be.

The above view is based upon the citation and the personal view of the author.


Please enter your comment!
Please enter your name here