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In the Drugs and Cosmetics Rules, 1945, in Schedule K, against serial number 23, for the entries under the column “Class of Drugs”, the following shall be substituted, namely:―

“Drugs supplied by (i) Health Functionaries including Community Health Officers, Nurses, Auxiliary Nurse Midwives and Lady Health Visitors attached to Primary Health Centres/ Sub-Centres/ Health & Wellness Centres in rural and urban areas, (ii) Community Health Volunteers such as Accredited Social Health Activists (ASHAs) under the National Health Mission, and (iii) Anganwadi Workers.”

Enclosed the original copy of the rules -
(318.66 KiB) Downloaded 82 times
Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 414A, D Wing, Nirman Bhavan,New Delhi -110011 or emailed at drugsdiv-mohfw@gov.in.

Overall, all the pharmacy related professional and student organization is opposing the implementation of the new D&C act Schedule K, due to the following reasons,

1. The proposal is ill conceived, highly injurious to public health and hazardous to life of people, because:

(i) It contradicts, contravenes and abrogates Section 42 of Pharmacy Act, 1948 (VIII of 1948);

(ii) It is derogatory to the aims and objects of Pharmacy Act, 1948 which guarantees dispensing of medicines by registered pharmacists only;

(iii) No person other than a registered pharmacist has any knowledge and expertise on medicines covering all aspects related to history, chemistry, pharmacokinetics, pharmacodynamics, pharmacotherapeutics, pharmacovigilance, manufacture, packaging, storage, preservation, usage, distribution and administration in such depth as required for rational use of medicines and safety, efficacy and economic dimensions of therapy;

(iv) All the categories of employees mentioned under (i) to (iii) in the proposal are not at all eligible to be registered as pharmacist and hence supply of any medicine by them is calculated attempt to deny the services of pharmacists and open challenge to necessity of pharmaceutical care so emphatically advocated by WHO in greater public interest.

(v) The safety and efficacy aspect of allopathic medicine is a matter of great concern all over the world and the following depiction is only the tip of the iceberg:

(a) Death by medicine is a 21st-century epidemic, and America's "war on drugs" is clearly directed at the wrong enemy
-By Dr. Mercola October 26, 2011

(b) Prescription drugs are now killing far more people than illegal drugs, and while most major causes of preventable deaths are declining, those from prescription drug use are increasing. An analysis of recently released data from the U.S. Centers for Disease Control and Prevention (CDC) by the Los Angeles Times revealed.

(c) The Times analysis of 2009 death statistics in Us revealed: “For the first time ever in the US, more people were killed by drugs than motor vehicle accidents. 37,485 people died from drugs, a rate fueled by overdoses on prescription pain and anxiety medications, versus 36,284 from traffic accidents. Drug fatalities more than doubled among teens and young adults between 2000 and 2008, and more than tripled among people aged 50 to 69.”

2. The above depictions prove beyond doubt that modern allopathic medicines are two edged weapon and their improper use plays havoc to life and heath of people in terms of morbidity and mortality. That is the reason why all welfare nations assure best quality pharmaceutical care for their citizens.

3. Legal prescription drug abuse is a silent epidemic, and is part of the reason why the modern American medical system has become the leading cause of death and injury in the United States.

4. A survey of a 1992 national pharmacy database found a total of 429,827 medication errors from 1,081 hospitals. Medication errors occurred in 5.22 percent of patients admitted to these hospitals each year. A minimum of 90,895 patients annually were harmed by medication errors in US as a whole.

5. A 2002 study shows that 20 percent of hospital medications for patients had dosage mistakes. Nearly 40 percent of these errors were considered potentially harmful to the patient. In a typical 300-patient hospital the number of errors per day was 40.

6. Problems involving patients' medications were even higher the following year. The error rate intercepted by pharmacists in this study was 24 percent, making the potential minimum number of patients harmed by prescription drugs 417,908.

7. In November 2003, Gary Null, et al. described in detail how everything from medical errors to adverse drug reactions caused more harm than good.

8. According to the White House Office of National Drug Control Policy, prescription drugs are second to marijuana as the drug of choice for today's teens. In fact, seven of the top 10 drugs used by 12th-graders were prescription drugs.

9. More than 40 percent of high school seniors reported that painkillers are 'fairly' or 'very' easy to get. They also reported that they believed that if they were to get caught, there was less shame attached to the use of prescription drugs than street drugs. This mirrors the perceptions of their parents, who, when queried said that they felt prescription drugs were a safer alternative to drugs typically sold by a drug dealer.

10. A 2003 study followed 400 patients after discharge from a tertiary care hospital. Seventy-six patients (19 %) had adverse events.

11. In a NEJM study an alarming one-in-four patients suffered observable side effects from the more than 3.34 billion prescription drugs filled in 2002.

12. The drugs with the worst record of side effects were the Selective serotonin reuptake inhibitors (SSRIs), the NSAIDs, and calcium-channel blockers.

13. NSAIDs most commonly affect the gastrointestinal tract (the stomach and intestines). Common side effects associated with the long-term use of NSAIDs include: indigestion, Stomach ulcer (a sore in the lining of the stomach). Stomach ulcers can sometimes cause more serious complications, such as: gastrointestinal bleeding – internal bleeding within the digestive system, Anaemia– where blood is unable to carry enough oxygen around the body which can cause shortness of breath and tiredness and gastrointestinal perforation – where a hole occurs in the wall of the stomach or intestine.

14. There is a plethora of research data to support restricted handling of medicines by registered pharmacists and government of a Welfare State should be vigilant to strictly enforce the provisions of Section 42 of Pharmacy Act, 1948 rather than attempting to dilute an Act of Parliament by a subordinate Rule under another Act.

To sign your petition,
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In view of the above, I vociferously object to the Draft Rule and earnestly request the Central Government to dump the proposal lock, stock and barrel the greater interest of health and happiness of the people of India.
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