The Hindu Editorial Analysis - 15th October 2022 | Current Affairs & Hindu Analysis: Daily, Weekly & Monthly - UPSC PDF Download

No Time for Placebo 

Why in News?

• India’s apex drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has barred Haryana-based Maiden Pharmaceuticals Limited from manufacturing medicinal drugs.
• The WHO analysis of samples of each of these products had confirmed the presence of “unacceptable amounts of diethylene glycol and ethylene glycol as contaminants”. 
• These ingredients are not allowed in food or drugs, as they can cause abdominal pain, vomiting, diarrhoea, headache, severe renal injury and neurological toxicity.
• The company said these were not sold in India and are only for export markets already approved by the DGCI.

What did the WHO say?

• “The four medicines are cough and cold syrups produced by Maiden Pharmaceuticals Limited, in India. They failed the test as they have unacceptable amounts of diethylene glycol and ethylene glycol as contaminants”, the global health agency stated.  
• According to the tentative results received by the WHO, four out of the 23 samples tested have been found to contain either Diethylene Glycol/Ethylene Glycol.
• All four syrups — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup – are made by Haryana-based Maiden Pharmaceuticals.

About World Health Organization (WHO)

• It is a particularized agency of the United Nations responsible for international public health
• The Headquartered Of WHO is in Geneva, Switzerland, it has six regional offices and 150 field offices worldwide
• It was established on 7 April 1948
• The WHO Constitution states its main objective as “the attainment by all peoples of the highest possible level of health”
• Laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.

The objectives of the WHO are

• To operate as the directing and coordinating authority on international health work
• To setup  and support effective collaboration with the United Nations, specialized agencies, governmental health administrations, professional groups and such other organizations as may be deemed appropriate
• To facilitate  Governments, upon request, in strengthening health services
• To furnish appropriate technical assistance and, in emergencies, necessary aid upon the request or acceptance of Governments
• To supply or assist in providing, upon the request of the United Nations, health services and facilities to special groups, such as the peoples of trust territories
• To establish and maintain such administrative and technical services as may be required, including epidemiological and statistical services
• To boost and advance work to eradicate epidemic, endemic and other diseases
• To encourage, in cooperation with other specialized agencies where necessary, the prevention of accidental injuries
• To encourage, in cooperation with other specialized agencies where necessary, the improvement of nutrition, housing, sanitation, recreation, economic or working conditions and other aspects of environmental hygiene
• To help in cooperation among scientific and professional groups which contribute to the advancement of health
• To develop conventions, agreements and regulations, make recommendations with respect to international health matters and perform

WHO and India

• India became a party of  WHO on 12 January 1948.
• The regional office for South East Asia is located in New Delhi.
• The first session of the WHO regional committee was held in 1948, and was inaugurated by Pandit Jawaharlal Nehru, Prime Minister of India and was addressed by the WHO Director-General

Di-ethylene Glycol and Ethylene Glycol

• Di-ethylene Glycol and   Ethylene Glycol are considered venomous for the human body. They can be the cause of kidney and neurological toxicity when consumed. This toxicity has been found a cause in several cases of mass poisoning when consumed via drugs.
• They are  Hygroscopic sweetish liquid which has no colour, and no particular smell. They can make a homogenous mixture of water, alcohol, ether, acetone, and ethylene glycol.
• The poisonous effects of Diethylene Glycol and  Ethylene Glycol can result in abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury.
• As per a paper in the National Library of Medicine, 10 DEG mass poisonings have occurred over the past 70 years. These mass poisonings were all caused by DEG-contaminated liquid or ointment medications. DEG contamination happens when it is used in medicinal products instead of safer—but more expensive—diluents such as pharmaceutical-grade glycerin.

Difference between Di-ethylene Glycol and Ethylene Glycol

• Ethylene glycol is commonly used in the manufacturing of  polyester fibres, paints and polyethene terephthalate (PET)
• On the other hand, DEG is used to break fluid in cigarette and paper treatment and also in some dyes, due to its hygroscopic property, 

How these contaminants enter the drug-supply chain

• Complexities in the distribution of glycerin and other pharmaceutical raw materials that may involve many import and export handlers cause these contaminants to creep into such glycerin-based medical products.
• DEG has also been used illegally as a cheap substitute solvent in drug manufacturing.
• As a result of it, it contributes to the risk of such adulteration is inadequate international regulations and the lack of analytical methods, according to scientists.

Symptoms  

• The adulterant can result in renal and neurological toxicity if ingested, which, in common language, they can affect the brain and kidney functions.
•  Acute kidney injury is commonly the main cause of death, which occurs anywhere between 8 and 24 hours after exposure if the dose is high.

What are the Related Regulations in India?

• The Drugs and Cosmetics Act:
  • The Drugs and Cosmetics Act, 1940 and Rules 1945 have entrusted various responsibilities to central and state regulators for regulation of drugs and cosmetics.
  • It provides the regulatory guidelines for issuing licenses to manufacture Ayurvedic, Siddha, Unani medicines.
  • It is mandatory for the manufacturers to adhere to the prescribed requirements for licensing of manufacturing units & medicines including proof of safety & effectiveness, compliance with the Good Manufacturing Practices (GMP).
• Central Drugs Standard Control Organisation(CDSCO):
  • Prescribes standards and measures for ensuring the safety, efficacy and quality of drugs, cosmetics, diagnostics and devices in the country.
  • Regulates the market authorization of new drugs and clinical trials standards.
  • Supervises drug imports and approves licences to manufacture the above-mentioned products.
  • CDSCO regulates export of drugs in India, any manufacturer with the certification from CDSCO can export drugs outside India.
• Drugs Controller General of India:
  • DCGI is the head of department of the CDSCO of the Government of India responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines and sera in India.
  • DCGI also sets standards for manufacturing, sales, import, and distribution of drugs in India.

Indian Pharmaceutical industry

• The Pharmacy of the World:
  • The Indian Pharmaceutical industry is the third largest in the world by volume. 
  • The Indian Pharmaceutical Industry has been using its powers very responsibly. 
  • It has made a name for itself and India is being called “The Pharmacy of the World” in some circles.

Export:

• India exported pharmaceuticals worth Rs 175,040 crore in the financial year 2021-22, including Bulk Drugs/Drug Intermediates. Also, India is one of the major producers of Active Pharma Ingredients (API) or bulk drugs in the world. 
• India exported Bulk Drugs/Drug Intermediates worth Rs 33,320 crore in the financial year 2021-22.

Imports:

• However, the country also imports various Bulk Drugs/ APIs for producing medicines from various countries. 
• Most of the imports of the Bulk Drug/APIs being done in the country are because of economic considerations.

What is driving the growth?

• Talent pool:
  • India has a huge talent pool with trained pharmaceutical professionals having degrees in B Pharmacy, D Pharmacy, M Pharmacy. 
• Generic drugs:
  • The ability of the pharmaceutical industry to develop generic drugs at a much-reduced price is mainly due to trained professionals in the industry. 
• Manufacturing:
  • India has a huge manufacturing base of pharmaceutical products giving it way more flexibility in producing generic drugs. 
  • India is home to 3000 drug companies and more than 10,000 manufacturing units.

Potential of the Indian Pharmaceutical Industry

• According to the Indian Economic Survey 2021, the pharmaceutical industry in India is expected to reach USD 120-130 Billion by 2030. 
• Industries related to the pharmaceutical sector:
  • The other industries related to the pharmaceutical sector like biopharmaceuticals, bio-services, bio-agriculture, bio-industry, and bioinformatics are likely to reach USD 150 Billion in 2025 as compared to USD 70 Billion in 2020.
  • According to EY and FICCI, Innovation and R&D, Healthcare Delivery, Manufacturing & Supply Chain, and Market Access are the opportunities that will drive growth in the years to come.