Wednesday, February 10, 2016

[Editorial # 62] Time for pharma course correction : The Hindu

[Following editorial has been published in The Hindu on 10th February 2016. Read through it and try to answer the questions that follow. Please do not copy and paste answers. The objective of this exercise is to get you in the groove of answer-writing. Try to write in your own words. Don't hesitate to write in a bulleted-format, if you are uncomfortable in writing in paragraph form.]

The Finance Ministry’s decision to withdraw customs duty exemptions for 76 life-saving drugs will at once make them more expensive and impact patients who are already paying a high price for such medical treatment. It is important to keep in mind that a majority of Indians meet health care costs through out-of-pocket expenditure, and any increase is bound to adversely affect them. It is true that the customs duty waiver is an interim measure, and that the list has to be revised periodically. Certain drugs now removed from the list are either no longer used by patients or are being manufactured in India at a lower cost than the imported ones, and therefore should be removed from it anyway. However, it is not clear what “public interest” is served by removing certain essential medicines that are either not manufactured in India or whose demand currently exceeds local manufacturing capacity. While the government has been enthusiastic about withdrawing the exemption for 76 drugs, it has failed to include certain life-saving or essential drugs that have been launched recently and are under patent protection. This indicates that consultations have not been broad-based; this has to be corrected as the patient’s interest should be the priority. Unlike in the case of other commodities where the consumer is the decision-maker, doctors’ prescription preferences, sometimes based on partisan considerations, dictate whether a patient ends up buying imported drugs even when locally manufactured options are available at a lower price. It is for this reason that the withdrawal of 22 per cent customs duty exemption on imported drugs could have an impact on a patient’s budget; imported active pharmaceutical ingredients (APIs) will also increase the cost of generics made locally.

Since the late 1990s, India has lost out to China in the API market. Active as well as enabling support from the government in various forms helped the Chinese industry flood the Indian market with cheap APIs. While the product patent regime that came into full force since 2005 and the flooding of the market with Chinese APIs may appear to be genuine reasons for giving the Indian industry cover to catch up, any protection cannot be long-lasting. The only way for the Indian drug industry to grow is by investing in research and development and in producing novel drugs that enjoy patent protection. India is the pharmacy of the South, but that dominance is restricted to generics. This has to change, and the government has to extend support in larger measure. As is the case in the U.S., many drugs that go on to become commercially profitable have their origins in academic and government institutions. Unfortunately, the recent decision to cut research funding will not help the industry. The earlier the government realises this and changes its priorities, the better it would be for the country.

Questions:

1. What are life-saving drugs? Explain with examples?

2. Which department/ministry is responsible for formulation of policies related to pharmaceutical industry?

3. What is Custom Duty? Why is it levied?

4. What is understood by patents? What are various domestic and international laws and agreement providing patent protection?

5. What is meant by Intellectual Property Rights? What are various types of IP which have been given protection under various laws?

6. What are Active Pharmaceutical Ingredients? What are their use?

7. What is meant by generic drugs? Why is it important to have generic drugs?

8. What are the factors responsible for India losing out in API market? How did govt. support the pharma industry to regain its market share?

9. What all measures should be taken by the government to encourage pharma industry's growth?

10. Assignment: Take any medicine strip and find out the information which is printed on it. Also find out the relevance of all such information.


22 comments:

  1. 1. What are life-saving drugs? Explain with examples?
    They are emergency drugs which require immediate administration in medical emergencies that can save the life of the patient. These medicines have the potential to sustain life or to prevent further complications.
    Some examples of life saving drugs are streptomycin, ethambutol, dapsone, etc.
    2. Which department/ministry is responsible for formulation of policies related to pharmaceutical industry?
    The Department of Pharmaceuticals under the Government of India is responsible for policymaking for the pharmaceutical industry in the country.
    3. What is Custom Duty? Why is it levied?
    It is a tax levied on the imports (maybe even exports) by the customs authorities of the country to raise the revenue of the State and also acts as a trade barrier to protect the home industry from foreign competition.
    The reasons for levy of custom duty are:
    i) To restrict imports for conserving foreign change.
    ii) To protect Indian industries from undue foreign competition.
    iii) To limit the import and export of goods for achieving the policy objectives of the Government.
    iv) To regulate export.


    4. What is understood by patents? What are various domestic and international laws and agreement providing patent protection?
    International treaties and conventions providing patent protection are:
    i) Paris Convention for the Protection of Industrial Property, 1883.
    ii) Patent Co-operation Treaty, 1970.
    iii) Strasbourg Agreement concerning the International Patent Classification (1971).
    iv) Budapest Treaty on the International Recognition of the Deposit of Microorganisms for purposes of Patent Procedure, 1977.
    v) Patent Law Treaty, 2000.
    The Patents Act, 1970 governs the patent regime in India.
    5. What is meant by Intellectual Property Rights? What are various types of IP which have been given protection under various laws?
    IPR are the rights given to persons over the creations of their minds. They usually give the creator an exclusive right over the use of his creation for a fixed duration of time. It is usually granted by a State.
    The different types of IPR are:
    i) Copyright: Rights of creators over their literary and artistic works.
    ii) Patents: Rights granted over an invention.
    iii) Trademark: It is a sign capable of distinguishing the goods and services of one enterprise from another.
    iv) Industrial designs: It constitutes the ornamental or aesthetic aspect of an article.
    v) Geographical Indications: These are sings used on products which originate from a specific geographical locations and possess characteristics specially attributed to that place of origin.

    ReplyDelete
    Replies
    1. 2. Pharmaceutical industry comes under Ministry of chemical and fertilisers

      Delete
  2. you could have written what these drugs are for . i mean to cure what disease

    ReplyDelete
  3. 6. What are Active Pharmaceutical Ingredients? What are their use?
    It is a substance or a combination of substances used in the manufacturing of a pharmaceutical product which is biologically active. It also refers to the central ingredient of any drug which causes an effect directly on the diagnosis, treatment of prevention of a disease.
    7. What is meant by generic drugs? Why is it important to have generic drugs?
    According to the World Health Organization, a generic drug is a pharmaceutical product which is usually produced with intent to be similar to an innovator product produced without a license from the innovator company and is sold after the patent of that product expires.

    ReplyDelete
  4. 6. What are Active Pharmaceutical Ingredients? What are their use?
    A. active pharmaceutical ingredietns is the finished product which may be either in liquid /tablet form to cure the diseases. API itself is the final product which is the combination of other ingredients. It restores the normal health of the individual.

    ReplyDelete
    Replies
    1. i'm wrong. they are the raw materials needed to make the finished product.

      Delete
    2. API (Active Pharmaceutical Ingredient) refers to a substance or substance combination used in manufacturing a drug product. API also refers to the active or central ingredient in the product which causes the direct effect on the disease diagnosis, prevention, treatment or cure.

      Delete
  5. 7. What is meant by generic drugs? Why is it important to have generic drugs?
    A.If the drugs are patented under the process patent, the same life saving drugs can be reverse engineered and a new drug to cure the same disease can be made. This reverses engineered drugs are called as generic drugs.
    Generic drugs are important as they bare the low cost than the patented drugs
    in case of life saving drugs they can be made available to all the citizens without compromising the objective of the health as social welfare.
    However, now a days all patents are being done under product patent where by any means such drugs cannot be prepared till the patent gets expired after 20 years.

    ReplyDelete
  6. 8. What are the factors responsible for India losing out in API market? How did govt. support the pharma industry to regain its market share?
    A. external factors:
    US decided to make its own API which imports from India and china that makes upto 80%
    internal factors:
    our dependency on china is high in importing API
    relaxing custom duties on life saving pharma drugs

    ReplyDelete
  7. What are life-saving drugs? Explain with examples?
    These are drugs which are generally used during the time of emergency and requires immediate administration. It has the potential of sustaining life and to prevent further complications that might lead to death.
    Drugs used in Anaplylactic shock :-
    Inj. Dexamethazone Sodium phosphate.
    Drugs used in Myocardial infarction and cardiogenic shock:-
    Inj. Isoprenaline.
    Drugs used in acute respiratory failure:-
    Inj. Nikenamide.

    ReplyDelete
  8. Which department/ministry is responsible for formulation of policies related to pharmaceutical industry?
    The Department of Pharmaceuticals was created on the 1st of July in the year 2008 in the Ministry of Chemicals & Fertilizers.
    Ananth Kumar is the Minister of Chemical and Fertilizers and Shri Hansraj Gangaram Ahir is the Minister of State for Chemicals and Fertilizers.

    ReplyDelete
  9. What is Custom Duty? Why is it levied?
    It is a type of indirect tax which is imposed on the goods which are imported into India as well as those goods which are exported from India.
    Export duties are levied occasionally. But import duties are levied extensively.
    The primary purpose for levying custom duty is to generate revenue for the state. It is also levied to protect the domestic goods from foreign competitors.

    ReplyDelete
  10. What is understood by patents? What are various domestic and international laws and agreement providing patent protection?
    Patents are set of exclusive rights which are given to an individual or a body corporate who is known as patentee, for a limited period of time(In India its 20 years) for the invention which the patentee has made in terms of any product or process.
    Domestic laws
    The Patents Act, 1970.
    International laws
    Paris Convention for the Protection of Industrial Property, 1883
    The Patent Cooperation Treaty (PCT), 1970
    Agreement on Trade-Related Aspects of Intellectual Property Rights.

    ReplyDelete
  11. What are Active Pharmaceutical Ingredients? What are their use?
    API are the portions of the drug which are active. It might be possible that a certain drug can have more than one API.
    Drugs are composed of two substances. One is API the other is known as excipient. Excipient are the inert substances which are present in the drug. It is the API which produces the desired result in the body.
    Example- If the drug is in the form of syrup then the liquid which has been used is the excipient.

    ReplyDelete
  12. 1. Life Saving drugs are the most critical and emergency powder in the form of medicine to cure the severe health issues. These are requiring in an immediate administration and demanded in the utter urgency in medical. These medicines have the potential to cure and let sustain the patient in a very critical situation.
    Examples: - Drugs used in the Anaplylactic shocks; Myocardial infarction and cardiogenic shock, Drugs used in peripheral circulatory collapse, used in status eplipticus and these drugs are also used in acute respiratory failure.
    2. Ministry of Chemical and Fertilizers is responsible for the administration of three major departments: 1.) Department of Chemical and Petrochemicals; 2.) Department of Fertilizers and Department of Pharmaceuticals. The ministry id headed by the Ministry of Chemical and Fertilizers and Chemicals which is currently headed by Ananth Kumar.
    3. CUSTOM DUTY: - It is one of the many forms of indirect tax over goods which are both imported into and exported from India. It provides for the levy and collection of duty on imports and exports, import and export procedures, prohibition on import and export of goods, penalties, and offences. The Central Board of Excise & Custom is the Apex body of the custom issues. The customs duty is levied for the following purpose: -

    Restricting Imports for conserving foreign exchange. It is levied for the protection of Indian Industry from undue competition, for the prohibiting of imports and exports of goods for achieving the policy objectives of the Government, regulating exports, prevent Smuggling, facilitate implementation of laws relating to Foreign Trade Act, Foreign Exchange Regulation Act, Conservation of Foreign Exchange, Prevention of Smuggling Act.

    ReplyDelete
  13. What is meant by generic drugs? Why is it important to have generic drugs?
    Generic drug is pharmaceutical product that can be used interchangeably with the innovator product. It is manufactured without obtaining license from the patentee but can be marketed only after the expiry of the term for which the product innovator had patent.
    These drugs are marketed under non-proprietary name or approved name rather than brand name. The brand name is exclusively reserved for its owner.
    These drugs are important because the affect of these drugs are similar to those drugs which had patent and were expensive. But since its a generic drug it would be very cheap and are generally accessible to the poor people.

    ReplyDelete
    Replies
    1. Generic drug: The term "generic" has several meanings as regards drugs:

      1. The chemical name of a drug.
      2. A term referring to the chemical makeup of a drug rather than to the advertised brand name under which the drug is sold.
      3. A term referring to any drug marketed under its chemical name without advertising.

      "Diazepam" is an example of the chemical (generic) name of a sedative. It is marketed by some companies under its generic name and by other companies under brand names such as Valium or Vazepam.

      Generic drugs marketed without brand names are generally less expensive than brand-name drugs, even though they are chemically identical to brand-name drugs and meet the same standards of the FDA (US Food and Drug Administration) for safety, purity and effectiveness.
      Generic drugs can be legally produced if a patent has expired, or for drugs which have never been patented. The expiration of a patent removes the monopoly of the patent holder on drug sales licensing.

      Delete
    2. Thank you for the additional information.

      Delete
  14. 4. Patent is the form of copyright, which enables an individual to protect his/her identity associated with the product created by that particular individual. Nobody else is empowered to get the duplicate or to use that product, design, pattern etc. in the fake name. Other person will be allowed to use it only after the selling of Patent, which is legal.
    The international protection of intellectual property has been a global issue of paramount importance. All countries acknowledge the need to protect "intellectual property". Intellectual property is an asset derived from the discovery or creation of a new product, process, or information, that has commercial value. Since nearly all traded goods operate under patent, copyright, or trademark protection, the fair and economic conduct of international trade is dependent upon secure intellectual property rights. Lack of international protection for the products of intellectual property can result in the loss in profits as a result of international piracy. Aware of the need to protect these valuable assets from piracy, the nations of the world sought to provide clear guidelines for intellectual property protection.

    In 1994, the signatory nations of the General Agreement of Tariffs and Trade signed the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPs), an ambitious international convention that set forth an international baseline for patent, copyright, and trademark protection.

    ReplyDelete
  15. 5. The term "Intellectual Property" refers to all the creation, inventions of an individual's mind. The designs, patterns, logo, idea, structure etc. belongs to one's effort of creation and invention. It is that property which cannot be allowed to share with an unwanted party, since it is an intellectual right of an individual's innovative intellectual property.
    IP is protected in law by patents, copyright and trademarks, which enable people to earn recognition or financial benefit from what they invent or create. By striking the right balance between the interests of innovators and the wider public interest, the IP system aims to foster an environment in which creativity and innovation can flourish.

    TYPES
    COPYRIGHT is a legal term used to describe the rights that creators have over their literary and artistic works. Works covered by copyright range from books, music, paintings, sculpture and films, to computer programs, databases, advertisements, maps and technical drawings.
    A PATENT is an exclusive right granted for an invention. Generally speaking, a patent provides the patent owner with the right to decide how - or whether - the invention can be used by others.
    A TRADEMARK is a sign capable of distinguishing the goods or services of one enterprise from those of other enterprises.

    ReplyDelete
  16. 9. Indian Pharmaceutical Industry is one of the leading in the world, and has witnessed particular growth after the year 1991 and specifically after 2005. Reasons for this could be seen in the following:
    a) The opening up of the economy in 1991 through the LPG;
    b) In 1995, India secured the membership of the WTO which gave a boost to all aspects of its trade, including pharmaceutical;
    c) Indian Patent Act 2005;
    d) TRIPS and Section 3(d) of Indian patent law.

    Despite being leading pharmaceutical products predominantly in generic medicine. India is lagging China in proportion. Indian government should encourage pharmacy sector in following ways:
    * by increasing research and development.
    * by imposing tax on imported drugs.
    * by creating institutions and mechanisms to reduce the time taken for granting permissions to set up pharmaceutical companies.
    * by giving incentives for drug makers to create new life saving drugs.
    * All lengthy processes, regulatory frameworks, patent grants, etc. should be made easier and faster.
    * For repeating diseases and epidemics, government can assure future mass purchase form companies.
    * government should raise the fund for research.
    * by Increasing the patent period by 5-10 years. This gives companies more time to get returns. This makes them charge lesser due to more time.

    ReplyDelete