1. Introduction

In a welfare State, rule of law plays a very vital role. As we are familiar with that law is codified into statutes. To give effect to a statute it should be interpreted as it is. Interpretation is the breath of a statute. Whenever the words are ambiguous the statute should be interpreted according to the intention of the legislature. Interpretation should not stop, because of interpretation we come to know the intention of the legislature as to why the statute has been passed.

Whenever the words in a statute are ambiguous it is the duty of the court to interpret the statute by referring to internal aids and external aids. Internal aids are inside the statute itself. Where the mind labours to discover the design of the legislature, it seizes everything from which aid can be given. In Bostan Sand & Co. v. United States , when the meaning of the language was plain, the courts were not to resort to evidence in order to raise doubts, Holmes J. said “That is rather an ax

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

iom of experience than a rule of law and does not preclude consideration of persuasive evidence if it exists. If the Congress has been accustomed to use a certain phrase with a more limited meaning than might be attributed to it by common practice, it would be arbitrary to refuse to consider that fact when we come to interpret a statute.” The meaning to be ascribed to an Act can only be derived from a considered weighing of every relevant aid to construction.

But when it comes to the external aids they stay outside the statute and prove a good aid in interpretation of the statute.

2. External aids to construction

Apart from the intrinsic aids to construction, such as preamble and the purview of the Act, the Court can consider resources outside the Act, called the extrinsic aids, in interpreting and finding out the purpose of the Act. Where the words of an Act are clear and unambiguous, no recourse to extrinsic matter, even if it consists of the sources of the codification, is the

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

intrinsic aids, such as preamble and purview of the Act. Sources outside the Act called extrinsic aids. These resources deal mainly with the history of the Act, both with the prior events leading up to the introduction of the Bill, Select Committee reports.

In Mohd Hanif Quareshi v. State of Bihar , the Supreme Court took in to the consideration the Report of the Uttar Pradesh Gosamvardhan Committee and the fact that three of the members of the committee were Muslims and had concurred in the unanimous recommendation for a total ban on slaughter of cows.

The courts have only to enquire, what has the legislature thought for to enact? As long ago as Heydon’s case, Lord Coke said: It was resolved that for the sure and true interpretation of all the statutes in general, be they penal or beneficial, restrictive or enlarging of the common law, four things are to be discerned and considered

a) What was the common law before the Act.
b) What was the mischief and defect for which the

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

common law did not provide.
c) What remedy the Parliament had resolved and appointed to cure the disease of the commonwealth.
d) The true reason for the remedy.

The rule upon the subject was well articulated in the case of Stradling v. Morgan , wherein it was said: “The judges of the law in all times past have so far pursued the intent of the makers of statutes, that they have expounded the Acts which were general in words to be but particular where the intent was particular. The sages of the law heretofore have construed statutes quite contrary to the letter, in some appearance, and those statutes which comprehend all things in the letter, they have expounded to extend but to some things, and those which generally prohibit all people from doing such an act, they have interpreted to permit some people to do it, and those which include every person in the letter, they have adjudged to reach some persons only; which expositions have always been founded upon the intent of the

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

legislature, which they have collected sometimes by considering the clause and necessity of making the Act, sometimes by comparing one part of the Act with another, and sometimes by foreign circumstances so that they have ever been guided by the intent of the legislature, which they have always taken according to the necessity of the matter and according to that which is consonant to reason and good discretion”.

It is appropriate to consider the state of law which it proposes or claim to alter, the mischief which existed and which it was intended to remedy, and the nature of the remedy provided and to look at the statute in pari materia as a means of explaining the statute. These external aids are the proper modes of ascertaining the intention of the legislature. “It is not the words of the law but the internal sense of it” that makes the law and the law consists of two parts, viz., body and soul, the letter of the law is the body of the law and the sense and the reason of the law

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

is the soul of the law. And it often happens that when you know the letter you know not the sense, for sometimes it is more large and extensive. As Supreme Court said, the courts should have regard not merely to literal meaning of words used, but also take into consideration the antecedent history of the legislation, its purpose and the mischief it seeks to suppress.

To know the evil which it is designed to remedy, the courts may properly look at contemporaneous events, the situation as it existed and it was pressed upon the attention of the legislative body. If the court finds that the meaning of a statutory provision is not clear in itself, it can examine the surrounding circumstances that led to or accompanied its enactment, that is, all those external or historical facts which are necessary for the comprehension of the subject matter, scope and object of an enactment. Recourse to extrinsic aid in interpreting a statutory provision would be justified only within well recognized

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

limits; and primarily the effect of the statutory provisions must be judged on a fair and reasonable construction of the word used by the statute itself. In coming to a determination as to the meaning of the a particular word in a particular Act, it is permissible to consider two points, namely, (a) the external evidence derived from extraneous circumstance such as previous legislation and decided cases etc., and (b) the internal evidence derived from the Act itself.

3. Effect of Usage and Practice

In construing old statutes, it has been customary to pay regard to the construction put upon them by the judges who lived at or soon after the time when the statutes were made because they were best able to judge of the intention of the makers at the time. In such cases a contemporaneous interpretation is the paramount and strongest in the law and ought to be adhered to unless it could be positively said that it was wrong and productive of inconveniences. The rule is that the words of

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

statute will be understood in the sense which they bore when it was passed. In other words, they are to be understood as used with reference to the subject matter in the intellect of the legislature and limited to it.

Usage or practice developed under a statute is problem-solving of the meaning ascribed to its words by contemporary opinion and in case of an ancient statute is a permissible external aid to construction.

A uniform notorious practice continued under an old statute and in action of the Legislature to amend the same are important factors to show that the practice so followed was based on correct understanding of law.

It is Communis opinion says Lord Ellenborough, He says: “It is the evidence of what law is” . When the practice receives judicial or legislative approval it gains additional weight and is to be more respected.

But a uniform and consistent departmental practice arising out of construction placed upon an ambiguous statute by the highest executive officer

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

s at or near the time of its enactment and continuing for a long period of time is an admissible aid to the proper construction of the statute by the Court and would not be regarded except for cogent reasons. The controlling effect of this aid which is known as executive construction would depend upon various factors such as the length of time for which it is followed, the nature of rights and property affected by it, the injustice resulting from its departure and the approval that it has received in judicial decisions or in legislation.

As to the legislative endorsement to a departmental practice Lord Machnaghten said: “When you find legislation following a continuous practice repeating the very words on which that practice was founded, it may perhaps fairly be inferred that the legislature in re enacting the statute intended those words to be understood in their received meaning. And perhaps it might be argued that the inference grows stronger with each successive re-enactment” .

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

Subject to use made of contemporary official statements and statutory instruments the principle of Contemporanea expositio is not applicable to a modern statute. Even if the persons who dealt with the Act understood it in a particular manner that does not prevent the court in giving to the Act its true construction. The doctrine is confined to the construction of ambiguous language used in very old statutes where indeed the language itself have had a rather different meaning in those days.

Where there are ambiguous statements in an Act passed one or two centuries ago it may be legitimate to refer to the construction put upon their expression throughout a long course of years by unanimous consent of all parties interested as exercising what must presumably have been the intention of the legislature at the remote period.

This principle of contemporanea expositio has a fifty-fifty chance to be applied by the Courts. The Supreme Court had refused to apply the principle to the Teleg

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

raph Act, 1885 and the Evidence Act, 1872. But the principle was applied in construing the Bombay Municipal Corporation Act, 1888 in case of National & Grindlays Bank v. Municipal Corporation for greater Bombay and reliance in that connection was placed on the observations of Lord Blackburn in Clyde Navigation Trustees v. Laird.

The question as to the application of the rule of contemporanea expositio arose in case of Governors of Campbell College etc. v. Commissioner of valuation, the Governors of a fee paying public school claimed that the school was exempted from rates being ‘used for charitable purposes’ within section 2 of the Valuation (Ireland) Amendment Act, 1854. It was accepted that if the test in Pemsel’s case applied, the school would be entitled to exemption, for educational purposes were in law charitable. It was, however, contended that under a longstanding practice supported by Alexandra College’s case the exemption had been confined to those educational chariti

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

es whose purposes were concerned with the education of the poor. The House of Lords held that the decision in Alexandra’s case was unsupportable and the school was entitled to the exemption. So the decision rendered in 1914 relating to the Act of 1854 was not contemporanea expositio. Even a longstanding practice sanctioned by judicial decisions as also recognized in textbooks and in legislation may be overruled if there was no legal basis for it and if in the changed circumstances its continuance led to great hardship. In Birmingham City Corporation v. West Midland Baptist , the House of Lords in 1969 overruled a century old practice of assessing compensation by reference to values prevailing at the date of the notice to quit and held the same should be assessed with reference to the values prevailing when possession is taken or when the assessment is made.

The principles of contemporanea expositio and executive construction though relevant for solving a case of an ambiguity cannot

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

be used for bringing about an implied repeal or quasi repeal. A acquiescence even for a long period does not make a void rule valid, but when rules are made by the Government under earlier enactments on the basis of a particular construction of the enabling section which is followed by omission of all concerned to dispute that construction for a long time by challenging the validity of the rules and enabling section is re-enacted without any material change, an inference arises that the construction on which the rules proceeded correctly represents the intention of Parliament and has its approval.

In N. Suresh Nathan v. Union of India, this case was relating to the construction of the service rule which enabled section of officers possessing a recognized Degree in Civil Engineering or equivalent to claim eligibility for promotion if they had put in three service in grade whereas six years was required to make a Diploma holder eligible for promotion, question was as to the point of

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

time from which the period of three years was to be counted in a case where the section officer obtained the degree during the service. The practice over a long period was to count the period of three from the date the officer obtained the degree and this practice was relied upon in construing the rule. It is was observed that if the past practice is based on one of the possible constructions which can be made of the rules then upsetting the same now would not be appropriate.

When a statute uses language of doubtful import, the acting under it for a long term of years may well give an interpretation to that obscure meaning and reduce that uncertainty to a fixed rule. In other words, when a legislative measure of doubtful meaning has, for several years, received an interpretation, which generally been acted upon by public, the courts should be very unwilling to change that interpretation, unless they see cogent reasons for doing so. This rule applies more strongly where the measure

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

relates not to any general principles of law, but to some technical or fiscal rule, such as the registration of documents, and where the interpretation which has been put upon the measure in the case of the general public.

4. Dictionaries

It is conventional principle of construction of statutes that in the absence of there being anything contrary to the context, the language of a statute should be interpreted according to the simple dictionary meaning of the terms used in the dictionary. When a word is not defined in the Act itself, it is permissible to refer to dictionaries to find out the general sense in which that word is under-stood in common parlance. It is not always safe way to construe a statute by dividing it by a process of etymological dissection and then to give each word some particular definition given by lexicographers.

The duty of the court is to interpret and give full effect to the words used by the legislature and it is really not relevant to find out what a pa

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

rticular branch of the public may or may not understand to be the meaning of those words. It is for the courts to interpret them as the best as they can. The courts in doing so may assist themselves in the discharge of their duty by any literary help which they can obtain, including of course, the consultation of standard authors and also a reference to well known and authoritative dictionaries which state where the interpretations which they give to the words of the English language are to be found. In Midland Rail Co., v. Robinson, Lord Herschell used Dr. Johnson’s dictionary to know the meaning of the word ‘mine’ but Lord Machnaghten said that on such a point the opinion of such Judges as Kindersly, V.C. Turner, L.J. and Jessel, M.R. was probably a safer guide than any definition or illustrations to be found in dictionaries.

Dictionaries cannot be taken as authoritative exponents of the meaning of words used because the plainest words may be controlled by reference to the conte

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

xt. A dictionary meaning cannot be adopted if it will make some existing words redundant or will require reading of some additional words. The words and expressions at times have a technical or a legal meaning and in that case they are understood in that sense.

A explanation of a particular word given in a lexicon in terms of a court’s decision should not be used unless the decision was given under an Act in pari materia with the Act in question. Judicial decisions expounding the meanings of words in construing statutes in pari materia will have more weight than the meaning furnished by the dictionaries. Dictionaries and reports from foreign countries are not safe guides. The safest guide is always the statute itself which is under consideration. Now days, dictionaries mainly law lexicons are becoming authoritative because they furnish the meaning of a term by referring to a statute or a judicial decision which may be landmark.

5. Foreign decisions

The construction of Indian

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

Statutes sobered use of foreign decisions of countries following the same system of jurisprudence as ours and rendered on statutes in pari materia has been permitted by practice in Indian Courts. The assistance of such decisions is subject to qualification that prime importance is always to be given to the language of the relevant Indian Statute, the circumstances and the setting in which it is applied and that it is enacted and the Indian conditions where it is to be applied and that is not to be forgotten that there is always an element of risk in taking ready and hasty assistance from such decisions. It is to be kept in the mind that reference is made to a foreign decision only when there is no guidance available in Indian decisions. So it is implied that if that is guidance available in the Indian decisions then referring to the foreign decisions becomes unnecessary.

Reference to the English decisions was a common practice in the pre-constitution period because of historical r

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

easons. Here is an illustration to the general rules were based on English decision. In Shaaban Bin Hussein v. Chang Fook Kam , in this case the section 23 of the Code of Criminal Procedure of Malaysia which empowers any police officer arrest any person against whom there exists a reasonable suspicion of his having been concerned in any seizable offence. The section corresponds to section 54 of the Indian Criminal Procedure Code and is helpful in interpreting the expression reasonable suspicion. In the context of the Criminal Procedure of the Malaysia the Privy Council said: “it is quite clear that the law of Malaysia has to be taken from the Code and from cases on the common law. But when the Code is embodying common law principles, decisions of the Courts of England and other Commonwealth countries in which the common law has been expounded can be helpful in the understanding and application of the Code.” The suggested limited application of foreign decisions is undoubtedly usefu

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

l in understanding an Indian statute which embodies a common law principle.

The same attitude of respect with the caution has been followed by the Supreme Court after advent of the Constitution which because of incorporation of fundamental rights has given more access to American precedents. It cannot be denied that our courts have gained considerable assistance from foreign decisions in interpreting certain provisions of our Constitution. When an Indian Act is replica of a prior English Act, decisions construing the provisions of the English Act are referred to as helpful guide for construing corresponding provisions of the Indian Act.

The use of English language as authoritative text of Indian Statutes is another factor which obliges the Indian Courts in taking recourse to foreign precedents of English speaking countries. E.g. even in construing a common place word ‘vegetable’ in taxing statute, reference was made to a Canadian decision interpreting the word in a similar statute

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products