Pharmachronicles

Top Menu

  • Home
  • Our Blog
  • Contact Us

Main Menu

  • Home Page
  • STUDENTS ZONE
  • Syllabus
  • Seminars & conferences
  • Online classes
    • Register
Sign in / Join

Login

Welcome! Login in to your account
Lost your password?

Lost Password

Back to login
  • Home
  • Our Blog
  • Contact Us

logo

  • Home Page
  • STUDENTS ZONE
  • Syllabus
  • Seminars & conferences
  • Online classes
    • Register
  • Overcoming Vaccine Hesitancy: How Pharmacists Build Patient Confidence

  • Resurgence of COVID-19 in Hong Kong and Singapore: A New Wave Driven by Waning Immunity and Emerging Variants

  • How Pharmacists Support Chronic Disease Management in the Community

  • OTC Medications: Safe Use, Common Mistakes, and Pharmacist Guidance

  • Pharmacovigilance Explained: Why Reporting Adverse Drug Reactions Saves Lives

BLOGS
Home›BLOGS›Industry wary over government’s new pharma policy

Industry wary over government’s new pharma policy

By admin
August 24, 2017
921
0
Share:

The current draft pharma policy may have a negative impact on growth and profitability of the industry due to continued emphasis on price control, say industry officials and analysts

Mumbai: India’s proposed pharmaceutical policy, if implemented in the current form, may have a negative impact on growth and profitability of the industry due to continued emphasis on price control, cap on trade margins and discontinuation of loan licensing or third-party manufacturing, industry officials and analysts said.

Several recommendations in the draft policy, though intended to be patient-friendly, are likely to hurt the industry, particularly the smaller players. The policy is prepared by the department of pharmaceuticals under the ministry of chemicals and fertilizers.

In a country where 65% of medical costs are out-of-pocket expenses, the government’s efforts to provide quality medicines to patients at affordable prices are in the right direction but such moves are expected to squeeze margins of pharma companies.

Proposals such as mandatory bio-equivalence and bio-availability tests for all drugs, adoption of World Health Organisation (WHO) quality standards by all manufacturing units, and phasing out of loan-licensing practice are likely to increase costs of companies, while cap on trade margins, implementation of “one company-one drug-one brand name-one price”, and government’s drugs price control order may keep pricing under pressure.

On the draft policy, D.G. Shah, secretary general of Indian Pharmaceutical Alliance said, “It appears to be a hurriedly prepared document with several flaws…It is more a product of perceptions than evidence. It will hurt patients by promoting proliferation of substandard and poor quality drugs, reducing competition and compromising availability. It will damage the industry by further slowing down growth and its profitability.”

“The policy document explicitly states providing a longer term stable policy environment for the sector which is much needed. However, the policy needs to ensure it addresses facts rather than perceptions. The continued focus on price control versus allowing market factors and quality to determine prices seems flawed. In the end, the patient will suffer if the manufacturing of good quality medicines at prevailing prices becomes a challenge and the government must be thoughtful on this,” Rahul Guha, partner and director at The Boston Consulting Group (BCG), said.

In a note dated 17 August, brokerage firm Nomura said the proposals favour large pharma companies, which adhere to relatively high standards of manufacturing and marketing practices, but are negative for smaller firms.

The draft policy document states that loan licensing raises many quality maintenance and assurance issues. Therefore, except in biopharmaceuticals where India is at a relatively nascent stage of development, in other pharmaceutical formulations, loan licensing is proposed to be phased out over three years and allowed up to only 10% of total production of the company and from a WHO-approved manufacturing unit.

B&K Securities said in a note that the proposal to discontinue loan licensing or third-party manufacturing would be negative for the industry as almost 40-50% of local drugs are sourced through loan licensing or contract manufacturing from small scale units.

“Instead of a blanket ban on loan licensing activity which would create excess un-utilised capacity, it would be better if central drug regulator brings loan licensing units under their audit protocol to ensure high quality standards are complied. If loan licensing is discontinued, the burden on the local pharma players would increase dramatically as companies will have to invest in capex plans or maybe acquire these SMEs (small and medium-sized enterprises) into their fold,” the brokerage said.

While the policy talks about the increase in use of generic names of drugs instead of brand names, it does not explicitly say that doctors will have to compulsorily prescribe medicines by their generic names, a move that was mentioned by Prime Minister Narendra Modi in early 2017.

“The draft pharma policy does not have the requirement of doctors prescribing the medicines through molecule/salt names (except procurement by public hospitals). The policy is based on the principle of ‘one company–one drug–one brand name–one price’. Even for public procurement, the policy allows the use of brand names for fixed dosage combinations. The key worry for the sector was use of generic names, and with the new draft policy not emphasizing on it, this removes a key overhang from the sector,” broking firm Credit Suisse said in a report dated 17 August.

Key points of draft New Pharma Policy:

01 – One manufacturer, one salt, one brand name, one price.

02 – Making essential drugs accessible & affordable to all.

03 – Providing longer term stable policy environment for companies.

04 – Making India sufficiently self-reliant in end-to-end indigenous manufacturing.

05 – Ensuring world class quality of drugs for domestic consumption & exports.

06 – Creating an environment for R&D to produce innovator drugs.

07 – No overwhelming benefit to the sector due to loan licensing.

08 – ‘Loan licensing’ only for up to 10% of total production of the company.

09 – ‘Loan licensing’ undermines veracity of drug manufacturing.

10 – 2,500 salts manufactured but there are 60,000 brands with varying prices.

11 – Will phase out policy allowing 1 drug companies to make multiple brands for other companies.

12 – A level of trade margins will be prescribed to create level playing field.

13 – E-pharmacy with adequate safeguards will be encouraged.

14 – Public procurement of drugs will be of generic drugs in salt names.

15 – Drug pricing to be poor-oriented & industry-friendly.

16 – National list of essential medicines will be basis for price control.

17 – Marketing practices of several pharma companies create an unfair advantage.

18 – Voluntary regulations for marketing practices to be made mandatory.

19 – New agency to look at violations in marketing practices.

20 – Approval time for applications to be fixed at 3 months.

21 – Chief Drug Regulator can extend approval time with reasons recorded.

22 – Brownfield FDI subject to continuance of drug manufacturing by entity getting FDI.

23 – Brownfield FDI subject to continuance of expenditure on R&D.

24 – Brownfield FDI subject to continuance of transfer of technology.

25 – New system to monitor adherence of brownfield FDI conditions.

Previous Article

FDA approved new drugs 2017

Next Article

JNTUH B.Pharm syllabus

0
Shares
  • 0
  • +
  • 0
  • 0
  • 0
  • 0

admin

Related articles More from author

  • BLOGSUncategorized

    How 3D Printing Revolutionizes the Future of Personalized Medicine

    August 15, 2024
    By Pharmachronicles
  • BLOGS

    Membrane vacuum cleaner as a new target for antibiotic resistance.

    October 18, 2017
    By admin
  • Phama news

    DIABETES MELLITUS

    January 13, 2020
    By Pharmachronicles
  • BLOGS

    NEW TOOL FOR THE IDENTIFICATION OF MALARIA

    October 24, 2017
    By admin
  • pharmaprofessor
    BLOGSPhama news

    Don’t Panic! Decoding the PCI Circular on Cutting Professors

    January 22, 2025
    By admin
  • Phama news

    ORAL CONTRACEPTIVES

    January 20, 2020
    By Pharmachronicles

Leave a reply Cancel reply

You may interested

  • DiseaseMedical & HealthMedical researchTreatment

    Can Psoriasis increase the risk of Type 2 Diabetes

  • Medical & Health

    Good Sleep, cheerful Mood can Stay Sharper In Old Age

  • BLOGSPhama news

    The Key Role of Pharmacy Professors at Private Universities & Autonomous Institutions of Pharmaceutical Sciences

  • LATEST REVIEWS

  • TOP REVIEWS

  • Pharmacists are not eligible for certificate program of community health

    0
  • A New Class of Antimicrobials Has Just Been Found in Human Breast Milk Fresh super ...

    0

Timeline

  • May 20, 2025

    Overcoming Vaccine Hesitancy: How Pharmacists Build Patient Confidence

  • May 17, 2025

    Resurgence of COVID-19 in Hong Kong and Singapore: A New Wave Driven by Waning Immunity and Emerging Variants

  • May 9, 2025

    How Pharmacists Support Chronic Disease Management in the Community

  • May 9, 2025

    OTC Medications: Safe Use, Common Mistakes, and Pharmacist Guidance

  • May 7, 2025

    Pharmacovigilance Explained: Why Reporting Adverse Drug Reactions Saves Lives

Latest Comments

  • Pharmachronicles
    on
    February 27, 2025
    Thank you sir

    Streamlining Salaries through Payment Credit System and Other Benefits for Pharmacy Professionals: Suggestive Measures for PCI ...

  • G Krishna moorthy
    on
    February 1, 2025
    Good 👍 efforts Congratulations Continue your valuable professional services

    Streamlining Salaries through Payment Credit System and Other Benefits for Pharmacy Professionals: Suggestive Measures for PCI ...

  • Aarati sonawane
    on
    January 31, 2025
    Use in toppical application

    Role of Artificial Intelligence in 3D Printing Personalized Medication

  • Sowmya V
    on
    December 13, 2019
    Nice keep it up

    Blood Test Might Predict Pregnancy Due Date and Preterm Birth

Find us on Facebook

Follow Us on Instagram

logo

Dui viverra Faucibus aliquet quis phasellus accumsan. Donec et facilisis sociosqu sed tortor elit eu aliquid turpis ridiculus.

Fly, shall, have greater fifth spirit midst under from stars thing is, had creepeth multiply kind. Man may they’re meat years have third bring replenish air two light deep fill.

About us

  • Dr.N.Sriram, Founder CEO, Pharmachronicles, HITS college of Pharmacy, Ghatkesar, Hyderabad, India
  • 9704361947
  • pharmachronicles@gmail.com
  • Recent

  • Popular

  • Comments

  • Overcoming Vaccine Hesitancy: How Pharmacists Build Patient Confidence

    By Pharmachronicles
    May 20, 2025
  • Resurgence of COVID-19 in Hong Kong and Singapore: A New Wave Driven by Waning Immunity ...

    By Pharmachronicles
    May 17, 2025
  • How Pharmacists Support Chronic Disease Management in the Community

    By Pharmachronicles
    May 9, 2025
  • OTC Medications: Safe Use, Common Mistakes, and Pharmacist Guidance

    By Pharmachronicles
    May 9, 2025
  • pharmacy credit system

    Streamlining Salaries through Payment Credit System and Other Benefits for Pharmacy Professionals: Suggestive Measures for ...

    By Pharmachronicles
    February 1, 2025
  • Blood Test Might Predict Pregnancy Due Date and Preterm Birth

    By Sundari srinidhi
    December 12, 2019
  • Ai in 3D printing

    Role of Artificial Intelligence in 3D Printing Personalized Medication

    By Pharmachronicles
    January 29, 2025
  • FDA is carefully evaluating prescription opioid medications approved to treat cough in children

    By admin
    July 16, 2015
  • Pharmachronicles
    on
    February 27, 2025

    Streamlining Salaries through Payment Credit System and Other Benefits for Pharmacy Professionals: Suggestive Measures for PCI ...

    Thank you sir
  • G Krishna moorthy
    on
    February 1, 2025

    Streamlining Salaries through Payment Credit System and Other Benefits for Pharmacy Professionals: Suggestive Measures for PCI ...

    Good 👍 efforts Congratulations ...
  • Aarati sonawane
    on
    January 31, 2025

    Role of Artificial Intelligence in 3D Printing Personalized Medication

    Use in toppical application
  • Sowmya V
    on
    December 13, 2019

    Blood Test Might Predict Pregnancy Due Date and Preterm Birth

    Nice keep it up

Photostream

    Follow us

    • Contact
    • STUDENTS ZONE
    • About Us
    © Copyright Pharmachronicles. All rights reserved.