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  IN THIS Article
 :: Introduction
 ::  Beginning of Gen...
 :: Indian Scenario
 :: Quality Issues
 :: Road Blocks
 :: The Way Forward
 ::  References
 ::  Article Tables

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  Table of Contents     
EDITORIAL
Year : 2019  |  Volume : 65  |  Issue : 2  |  Page : 67-69

Generic drugs – The Indian scenario


1 Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India
2 Department of Pediatrics, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India

Date of Web Publication26-Apr-2019

Correspondence Address:
Y C Shetty
Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jpgm.JPGM_420_18

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How to cite this article:
Joshi S S, Shetty Y C, Karande S. Generic drugs – The Indian scenario. J Postgrad Med 2019;65:67-9

How to cite this URL:
Joshi S S, Shetty Y C, Karande S. Generic drugs – The Indian scenario. J Postgrad Med [serial online] 2019 [cited 2019 Sep 22];65:67-9. Available from: http://www.jpgmonline.com/text.asp?2019/65/2/67/257287





 :: Introduction Top


A generic drug is a medication created to be the same as an existing approved brand name drug in dosage form, safety, strength, route of administration, quality, and performance characteristics.[1]


 :: Beginning of Generics Top


On September 24, 1984, in the 98th United States Congress, the act named The Drug Price Competition and Patent Term Restoration Act was passed, informally known as the Hatch-Waxman Act, encouraging the manufacture of generic drugs by the pharmaceutical industry and established the modern system of government generic drug regulation in the United States.[2]

The requirement was an abbreviated new drug application (ANDA) to be submitted by the pharmaceutical companies to the regulatory authorities for getting the approval to market a generic drug. ANDA process does not require the manufacturer to carry out repeat testing of generics in animals which is often time-consuming, as their branded versions have already been tested and approved for the safety and effectiveness. They are formulated when patent and other exclusivity rights of the innovator have expired.[3]

Generic drug manufacturers do not have to spend extra money for drug discovery and preclinical and clinical trials. Generics are available at a lower cost; they provide an opportunity for savings in drug expenditure in a country.


 :: Indian Scenario Top


As India is one of the highest per capita out-of-pocket expenditures' country, such generics will save a lot of money which can be used for other health issues.[4] In all the countries, use of generic drugs has increased significantly in recent years.[5],[6]

The regulations governing the approval of generic drugs are somewhat the same world over, with very few differences in developing countries, as in this part of the world it is not mandatory to undergo bioequivalence (BE) studies for getting approval for generics, and the gold standard considered for regulation in this field is United States.[3]

In 2008, the Government of India, through the Department of Pharmaceuticals, started a new initiative “Jan Aushadhi” (a Hindi word literally translated as “Medicine for People”). This program envisaged making unbranded quality medicines available to poor people in the country at a reasonable and affordable price through retail outlets' setup with the help of the government. It has taken ownership of setting up Jan Aushadhi stores, which are pharmacies selling only generic name medicines to the extent possible, giving preference to pharmaceutical public sector undertakings too.[7] Until March 15, 2018, 3200 Jan Aushadhi stores were operating in more than 33 states/union territories across India.[8] There are not enough Jan Aushadhi stores, possibly 3200 against more than 8 lakh retail pharmacies in existence, with many rural areas still underserved.[8]

The Medical Council of India, in an amendment to the code of conduct for doctors in October 2016, has recommended that every physician should prescribe drugs with generic names legible and he or she shall ensure that there is a rational prescription which promotes the use of generic drugs.[9] In future, the Government of India may bring a legal framework under which doctors will have to prescribe generic medicines to patients.[5]


 :: Quality Issues Top


Generic medicines are typically 30%–80% cheaper than originator equivalents.[5] The question raised quite often is “Whether the quality and performance of generic drugs is comparable to the brand drugs?” The proponents of generic drugs claim that they are equally effective as brand or innovator drugs.[4] Subsequent to this claim, the Drugs Technical Advisory Board of India in May 2016 considered amending Rule 65 (11A) of the Drugs and Cosmetics Act, 1940, so that pharmacists can dispense generic name medicines and/or equivalent brands against prescriptions in brand names. However, skeptics have stated that the use of generic drugs may lead to prolongation of illness or even therapeutic failure as the bioavailability (BA) of a generic drug may not be as good as that of the prescribed brand.[9]

Hence, the critical issues that affect the quality of generic drugs are purity, potency, stability, and drug release, and these should be controlled within an appropriate limit, range, or distribution to ensure the desired drug quality.


 :: Road Blocks Top


The government should ensure uniform quality across all the generics, and experts in the field of medicine say only then will doctors prescribe them willingly and with confidence.

One of the main reasons for lack of confidence in generic drugs among doctors (and even patients) has been the absence of stringent regulatory requirements for the quantity of the drug in its generic version and the permissible impurities in it.[10] But since 2016, clear-cut guidelines have been formulated which state that there should be 90% confidence interval of generic-drug-to-brand-drug ratio for key pharmacokinetic parameters [maximum concentration (Cmax) and area under curve] to lie between 80% and 125% of 1.00.[11] BEs (in vivo) are required by the regulators to ensure that the pharmaceutical equivalent reference product is therapeutically equal to the standard reference product. In certain situations, in vitro dissolution study is sufficient for showing equivalence between two drug products. But for highly water-soluble Biopharmaceutics Classification System (classes 1 and 3), immediate release products using currently available excipients and manufacturing technology, an in vivoin vitro correlations, may not be possible.[12] Tramadol, paracetamol, levofloxacin, memantine, moxifloxacin, and temozolomide were given BE waiver by Indian regulator as this drug substances were highly soluble and highly permeable.[13]

To ensure that the quality of generic drugs is equivalent to its branded version and that this equivalence is scrupulously maintained, the government should also bring legislation to ensure compliance in generic drug manufacturing and testing.[11]


 :: The Way Forward Top


Currently, undergraduate medical students learn the concept of generic drugs during their second MBBS teachings in pharmacology. Beyond this initiation, the importance of generic drugs in reducing patient expenses is not adequately emphasized during their further undergraduate and postgraduate training. Experts who formulate medical education curriculum would have to address this lacuna to ensure that future practicing physicians are well versed and comfortable in prescribing generic drugs [14]

Pharmacies and drug stores other than in government-run hospitals and clinics hardly stock unbranded generic drugs. When a generic drug is prescribed, it is likely that the pharmacist would dispense his favorite branded generic. Unless the prescribers are sure about the quality of generic drugs, compulsory prescribing in generics holds no breath in it.[10] Central Drugs Standard Control Organization is a licensing authority in India which has recently released guidelines for BA/BE studies.[11] It has given a checklist for submission of documents before undertaking BA/BE study, but is not clear whether they will ensure bioequivalence of each and every molecule. Confidence and habit of generic prescribing need to be inculcated into our medical fraternity by providing information and education particularly in areas of bioequivalence, regulatory aspects, and dispelling myths, fears, doubts, or false ideas about generic medicines. Only providing guidelines will not enhance quality drugs in market and prescribing. On the other hand, ensuring quality with strict regulatory mandate and providing updated information regarding the generic drugs (as given by United States Food and Drug Administration in its Orange Book) will eventually enhance prescription of generic drugs. The Orange Book provides information of approved drug products with therapeutic equivalence evaluations on a monthly basis.[15] It serves as public information to state health agencies, prescribers, and pharmacists to promote public education in the area of drug product selection.[15]

Godman et al[16] have proposed a 4”E” (Education, Engineering, Economics, and Enforcement) methodology for promoting generic drug utilization and development in Europe [16]; and the same can be replicated in India. The 4”E” include: (i) “Education” - design programs to influence generic prescribing by disseminating educational materials; (ii) “Engineering” - Focus on organizational interventions to evolve agreements on the price and volume of existing drugs in relation to disease management programs; (iii) “Economics”: Increase generic drug utilization through the use of positive and negative incentives for physicians and patients (iv) “Enforcement”- initiate regulatory or law enforcement methods which may include mandatory generic substitution laws to which pharmacists must adhere.[16] Well-designed survey studies should be planned especially taking in consideration patients, community pharmacists, and physicians to infer a general picture relevant to attitudes in generic drug prescribing.

Healthcare expenditure continues to rise in countries where healthcare is not a priority. Healthcare providers and policymakers need to keep drug prices affordable. Generic drugs offer an important tool for reducing the overall healthcare expenditure.[17] As more and more patents expire, the generic versions of the pharmaceutical market are expected to continue for increased sales. A sample list of generic drugs available in India along with their indication is depicted in [Table 1].
Table 1: Cost price of a few generic drugs

Click here to view


With the availability and usage of generic drugs, the experience with these drugs will increase and it will be possible to compare the real-time effectiveness of generic drugs vis-à -vis brand drugs.

Only after real-time effectiveness of generic drugs is documented and made published, will physicians be able to easily convince patients, including the wealthy, to take generic drugs.[18] Our government can achieve this goal, if the regulator maintain high standards for safety, efficacy, and quality in the review of generic drugs.

If sponsors, healthcare providers, and regulators work together effectively, then effective use of generic drugs will make medical costs cheaper and also ensure sound treatment options for the patients.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
 :: References Top

1.
Generic Drug Facts. Fda.gov. 2018 [cited 2018 Apr 12]. Available from: https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/GenericDrugs/ucm16799.  Back to cited text no. 1
    
2.
Kelly C. The balance between innovation and competition: The Hatch-Waxman act, the 2003 amendments, and beyond. Food Drug Law J 2011;66:417-78.  Back to cited text no. 2
    
3.
Swain S, Dey A, Patra CN, Bhanoji Rao ME. Pharmaregulations for generic drug products in India and US: Case studies and future prospectives. Pharmaceut Reg Affairs 2014;3:2  Back to cited text no. 3
    
4.
Gota V, Patial P. Toward better quality of anticancer generics in India. Indian J Cancer 2014;51:366.  Back to cited text no. 4
[PUBMED]  [Full text]  
5.
Dunne S, Shannon B, Dunne C, Cullen W. A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study. BMC Pharmacol Toxicol 2013;14:1  Back to cited text no. 5
    
6.
Wouters OJ, Kanavos PG, McKEE M. Comparing generic drug markets in Europe and the United States: Prices, volumes, and spending. Milbank Q 2017;95:554-601.  Back to cited text no. 6
    
7.
Janodia M. Differences in price of medicines available from pharmaceutical companies and “Jan Aushadhi” stores. Value Health 2015;18:A850.  Back to cited text no. 7
    
8.
Singh SK. Bureau of Pharma PSUs of India (BPPI) (Under Department of Pharmaceuticals, Govt of India) [Internet]. Message from CEO 2018 [updated 2018 Mar 15; cited 2018 Sep 15]. Available from: http://janaushadhi.gov.in/mesgceo.aspx.  Back to cited text no. 8
    
9.
An analysis of generic medicines in India. The Hans India. 2017 [cited 2018 Apr 12]. Available from: http://www.thehansindia.com/posts/index/Civil-Services/2017-05-09/An-analysis- of-generic-medicines-in-India/298834.  Back to cited text no. 9
    
10.
Andrade C. Bioequivalence of generic drugs: A simple explanation for a US Food and Drug Administration requirement. J Clin Psychiatry 2015;76:e742-4.  Back to cited text no. 10
    
11.
Revised checklist for BA/BE NOC effective from 01st February 2014. Cdsco.nic.in. [cited 2018 Apr 12]. Available from: http://www.cdsco.nic.in/writereaddata/BABE%20website%202014%20revised%20document%20required.pdf.  Back to cited text no. 11
    
12.
Guidance for Industry Dissolution Testing of Immediate Release Solid Oral Dosage Forms [cited 2018 Oct 15]. Available from: https://www.fda.gov/downloads/drugs/guidances/ucm070237.pdf.  Back to cited text no. 12
    
13.
Biowaivers: Criteria and Requirements – MOPH –2015 (Internet)[cited 2018 Dec 23]. Available from: https://www.moph.gov.lb/DynamicPages/download_file/538.  Back to cited text no. 13
    
14.
Kamath A. Prescribing generic drugs using a generic name: Are we teaching it right? Ind J Med Ethics 2016;1:194.  Back to cited text no. 14
    
15.
Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) [cited 2018 Oct 15]. Available from: https://www.fda.gov/drugs/informationondrugs/ucm129662.htm.  Back to cited text no. 15
    
16.
Godman B, Shrank W, Andersen M, Berg C, Bishop I, Burkhardt T, et al. Policies to enhance prescribing efficiency in Europe: Findings and future implications. Front Pharmacol 2011;1:141.  Back to cited text no. 16
    
17.
The telegraph online edition. 73 percent cut at fair price medicine shop published 20.3.15(Internet) [cited 12 November 2018]. Available from: https://www.telegraphindia.com/states/west- bengal/73-per-cent-cut-at-fair-price-medicine-shop/cid/1468788.  Back to cited text no. 17
    
18.
Marzo A, Porro E, Barassi A. Generic drugs: Myths, facts, and limitations. Ital J Med 2012;6:146-52.  Back to cited text no. 18
    



 
 
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