INTRODUCTION:

The purpose of prescribing any drug is to evoke its intended effect which may either be diagnosis, prevention, treatment and cure of any disease or disorder. This purpose of taking a drug may get vitiated if it fails to give its intended or desired effect which may lead to false diagnosis, aggravation of disease condition or delayed treatment. For example, someone takes an antipyretic drug like Paracetamol to lower the body temperature to normal and if this fails to do so, then the continuous high fever may lead to damage of the vital organs of the body, lead to permanent disability, morbidity or mortality.

The consequences may be far grave if we imagine this scenario on a larger scale in an endemic or pandemic situation which may not only lead to individual health concerns but the mass health, social and economical concerns^1,2.

A drug which is ensured to give its intended effect is called the standard drug. This standard quality of a drug has to be ensured by the drug developers, which further needs to be controlled by the concerned national regulatory agency before the same being consumed by the recipients. Hence the standards of drugs are specifically defined and published in the standard official compendia called Pharmacopoeia (sometimes additionally, being specified in the schedules annexed with drug related legislations), which are mandatorily needs to be complied by the manufacturer or importer of drugs. The developed countries like USA, Europe, Australia or Japan, all have their dedicated national regulatory agencies like US Food and Drug Administration (FDA), European Medicine Agency³ (EMA), Therapeutic Goods Administration (TGA) or Pharmaceutical and Medical Devices Agency⁴ (PMDA), respectively^5,6. These agencies work by their respective legislations like Federal Food Drugs and Cosmetics Act (FFDC) or European Directives and Pharmacopoeia like United Stated Pharmacopoeia (USP), European Pharmacopoeia (Ph. Eur.) or Japanese Pharmacopoeia (JP).

World health organization (WHO) Viewpoint on Availability of Standard Quality drugs worldwide:

World health organization (WHO) has reported that the issue of availability of substandard drugs can’t be denied in any of the countries. Its observation is quoted as, “No country remains untouched by this issue. What was once considered a problem suffered by developing and low income countries has now become an issue for all. With the exponential increase in internet connectivity, those engaged in the manufacture, distribution and supply of Substandard and falsified medical products have gained access to a global market place. This extends both to consumers and business to business forums. A culture of self-diagnosis and self-prescribing has led to the emergence of thousands of unregulated websites providing unsupervised access to Substandard and falsified medical products”¹.

Definition of standard drug:

As per WHO, “Substandard and falsified (SF) medical products are medicines, devices and other products manufactured to imitate or replace similar certified products. These products may contain either the false active ingredient or the inappropriate amount of the correct active ingredient or no active ingredient at all”¹.The 63^rd World Health Assembly proposed that since there is no consensus on the definition of Standard quality medical products, hence to cover all types of poor quality drugs under single umbrella framework, the term ‘substandard/spurious/falsely-labeled/falsified/ counterfeit⁷ medical products’ which is abbreviated as ‘SSFFC’ should be used⁵.

Other terminology like fake drugs, counterfeit drug or falsified drugs is not expressly defined in the said Act 1940. Hence for a drug to be treated as standard drug, it needs to fulfill all the criteria mentioned in section 16 of the said Act 1940 and should not fall in any of the parameters of section 17, 17A or 17B of the said Act 1940.

Enactment of Drugs and Cosmetics Act 1940:

In India, the wave to regulate the availability of standard drugs started before independence around World War-I, as sans legislation, the prevalence of substandard drugs become rampant. In August 1930, the Government of India appointed a Drugs enquiry committee under the Chairmanship of Colonel R.N. Chopra, which recommended the enactment of comprehensive legislation to prevent the prevalence of substandard drugs. This initiative eventually bore the fruit in the year 1940 when the Indian Drug bill received the assent of Governor General of India and became the Drugs Act 1940. This Drugs Act 1940 after amendment in the Year 1962 becomes the Drugs and Cosmetics Act which is “An act to regulate the import, manufacture, distribution and sale of drugs and cosmetics”. This act has 38 sections (which are grouped in five chapters) and two schedules⁹.

Drugs Rules 1945:

To implement all the provisions of said Act 1940, the comprehensive rules were framed in the year 1945; called Drugs Rules 1945 in which every parameter related to the implementation and promulgation of the provisions of Drugs and cosmetics Act 1940 was explicitly defined. Even the procedures for compliance of the different provisions of this act by regulatory agency officials, importers, manufacturer and distributors were prescribed meticulously The drugs and cosmetics rules 1945 consists of a set of 168 rules^9,10(being grouped in nineteen parts) along with a twenty six schedules being named after English alphabet like schedule A, B, C and five appendix.

Amendments in Drugs and Cosmetics Act 1940:

Since the enactment of the Drugs Act 1940 and Rules 1945 made there under, the Indian government has continuously upgraded the same by amending, inserting and substituting the provisions of said Act and rules to ensure the availability of standard drugs⁹. The major amended acts of the Act 1940 came in the year 1955, 1960, 1962, 1964, 1972, 1982, 1986 and 2008 respectively. These amended acts improved the execution of control of drug and related substances like The Drugs and Cosmetics (Amendment) Act 1955 and 1960 widened the definitions of Drug to include disinfectants and contraceptives and mandated the labeling of ingredients on Proprietary medicines. The Drugs and Cosmetics (Amendment) Act 1962 extended its provisions to Cosmetics so that import, manufacture and sale of Cosmetics can be controlled as per Drugs. The Drugs and Cosmetics (Amendment) Act 1982 included the term and definition of spurious drugs thereby protected the interest of genuine manufacturers and controlled black-marketing and counterfeiters. One such amendment made in the year 2008 had taken very bold steps to deter the perpetrators involved in trade of not of standard (NSQ)/misbranded/adulterated/spurious drugs in India.

The Drugs and Cosmetics (Amendment) act 2008:

“An act being enacted to amend the Drugs and cosmetics Act 1940 by Parliament of India and being came into force by notification dated 10^th August 2009”.

This amended act has made amendments in the penal provisions enshrined in the parent act for non compliance of the mandatory provisions which ensure the availability of only standard quality drugs. Infact, some of the offences pertaining to the manufacture or sale of spurious or adulterated drugs are made so grave that the a punishment from ten years imprisonment upto life imprisonment can be given to the perpetrators by the Honorable Judicial system of India. Further the fine in such case has been increased manifold which is not less than ten lakh rupees. Even to fast track such cases, the special courts had been notified in each session division which was equivalent to session courts in their powers. Some of the major sections being added or substituted are enumerated below.

Section 27- Penalty for manufacture, sale etc. Of drugs in contravention of the chapter IV of Drugs and cosmetics Ac 1940¹¹: In this section, punishment has been enhanced which ranges from imprisonment of term of seven to ten years (life term in grave case) and fine liabilities to the tune of ten lakh rupees were substituted with the previous lesser punishments in case of manufacture or sale of adulterated or spurious drugs.

a. Section 32- Cognizance of offences¹¹: Under this section, the cases under this act have been made to be trial able by Court of Sessions.

b. Section 36AC- Offences to be cognizable and Non-bailable in case of adulterated or spurious drugs^[11]: All the offences related to adulterated or spurious drugs had been categorized as cognizable (allow arrest of accused by Investigation Officer without warrant of Court) and non-bailable.

So the Government is fully prepared to deal with anybody who shall create hindrance in its mission to make availability of quality drugs to the patients/consumers.

Even during the writing of this review article, the Govt. of India has introduced the Draft of new bill i.e. Drugs, Medical Devices and Cosmetics Bill 2022. This bill after enactment will bring the sea change in regulation of therapeutics in India. As in contemporary time with the evolving science and technology, the treatment not only involves medicines but a number of different medical devices¹². In this bill, the provisions are enacted to have substantial control on all three pillars of medical or health streams i.e. drugs, medical devices and cosmetics ¹³. So this bill will prove to be a giant step towards the availability of only standard drugs, medical devices and cosmetics in India.

Amendments in Drugs and Cosmetics Rules 1945:

The provisions of Drugs and Cosmetics Act are being implemented through the prescribed procedures in the form of rules called Drugs and cosmetics Rules 1945. The parent Rules 1945 has also being amended with time to time to withstand the amended Act. A few of major amendments and new rules framed in this context are being detailed herein.

1. Drugs and Cosmetics (Fourth Amendment) Rules 2013¹⁴: Introduced Schedule H1 having list of Resistance prone Antibiotics including Higher Antibiotics, Anti-Tuberculosis drugs and Drugs that could be misused at large for Intoxication.

2. The Medical Devices Rules 2017 being implemented w.e.f. 01.01.2018^15,16: With the advent of medical device industry, the specialized set of Rules was framed which deals with exclusively all aspects of medical devices.

3. The New Drugs and Clinical Trials Rules 2019 being implemented w.e.f. 19.03.2019^17,18: To control the new drugs development and clinical trials and ensure the express and transparent procedure for compensation to clinical trial subjects (in case of any adverse incident) in tune with Good clinical Practices, these rules were framed.

4. The Cosmetics Rules 2020 being implemented w.e.f. 15.12.2020^19,20: To more efficiently regulate the import, manufacture and sale/distribution of cosmetics, a new set of Rules were framed independently from the Drugs and cosmetics Rules 1945.

A voluminous survey to confirm the Extent of Problem of NSQ and Spurious drugs in India:

At different times, to introspect the effect and outcome of regulatory framework; the Indian Government has executed the different types of surveys under aegis of different regulatory Institutions. In the year 2009, “Report on Countrywide Survey for Spurious Drugs” has been published by CDSCO on behalf of Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India. As per this report, 24136 samples were collected all over India with the help of NGOs /consumer associations. The report observed the extent of spurious drugs as 0.046%^21,22]. Before this, in February, 2003, an expert committee was constituted under Chairmanship of Dr. R.A. Mashelkar, DG (CSIR) which compiled the year wise substandard sample data collected from different States Drug controlling authorities for the year 1995 to 2008 and the said committee quoted the year-wise decreasing trend in NSQ drug cases from 10.6% to 6.3%²².

One such survey, quoted as the world’s most unique and voluminous survey being conducted in the year 2014-2016 by the apex level institution namely National Institute of Biological, Noida (India) with the statistical expertise of Indian Statistical Institute, Hyderabad at the cost of USD 1.25 Millions²³. This survey stands out to be most unique when compared with the 47 Global Drugs Quality Surveys published during the years 1992-2015²⁴.

As per the finding of this survey, the estimated availability of not of standard quality and spurious drugs is 3.16% and 0.0245% respectively in India²⁵. In other words, by reciprocating the calculations, it can be estimated that 96.8155% drugs available in India are Standard drugs^26,27. These statistics are presented in Figure 1 as pie diagram.

Figure 1: Pie Diagram to show the Prevalence of Standard and Sub-standard drugs in India, as per survey 2014-2016.

The data compiled by different committees and institutions during different surveys since 1995 to 2016, showed the downward trend in the prevalence of NSQ and spurious drugs respectively, as explained in Figure 2 and 3, which underlines the continuous efforts of the Indian Government in this mission of ensuring the prevalence of standard drugs in India.

Figure 2: Representing downward trend in prevalence of NSQ drugs in India from 1995 to 2016.

Figure 3: Representing downward trend in prevalence of spurious drugs in India from1995 to 2016.

CONCLUSION:

It is quite clear beyond doubt that the Indian Government is committed to ensure the consumer’s right to access the drugs that are safe and of standard quality only. Notwithstanding the fact that no country in the world has achieved the cent percent presence of standard drugs/therapeutics, as reported by WHO, the endeavour of Indian Government are quite commendable as it minimized the presence of substandard drugs to fractions only. Although this fact can’t be ignored that not a single unit of drug is affordable to be substandard but still the successful efforts made by India in this domain in journey of last 75 years need to be appreciated especially when the whole countrymen are celebrating the 75^th anniversary of Indian Independence i.e “Azadi Ka Amrit Mahotsav” in India and abroad. Further, the latest draft of Drugs, Medical devices and Cosmetics Bill 2022 will prove boon for the heath of the society by debugging any left out lacunae in the contemporary regulatory network.

ACKNOWLEDGEMENT:

The authors are appreciative to the Chitkara College of Pharmacy, Chitkara University, Punjab, India for providing the necessary facilities to carry out the work.

CONFLICT OF INTEREST:

The authors declare no any conflicts of interest.

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27. SEARPharm Forum. Extent of Spurious (counterfeit) Medicines in India, 2007 available on https://www.researchgate.net/publication/268519536_EXTENT_OF_SPURIOUS_COUNTERFEIT_MEDICINES_IN_INDIA 29th Dec. 2022.

Received on 16.02.2023 Modified on 04.10.2023

Research J. Pharm. and Tech 2024; 17(7):3079-3083.

DOI: 10.52711/0974-360X.2024.00482