NDPS Amendment Bill 2011 - Frequently asked questions
1. What is the NDPS Act about?
This is the regulatory Act of 1985 that governs the availability and accessibility of group of
drugs called ‘narcotics’ and ‘psychotropics’ which have medical value. Currently the scope
of the Act does not address the accessibility and availability issues of essential narcotic
drugs for medical treatment of patients in severe pain.
2. What exactly are “opioids” and “narcotics”?
Opioids are derivatives of opium e.g. morphine and other synthetic substances with similar
actions. They are most essential for managing moderate to severe pain conditions and
allow the person to get back to normal activities. The term “narcotic” is the legal term used
to mean the same thing within the NDPS Act.
3. Why is the earlier Act of 1985 inadequate?
Patients with severe pain in India are not able to get opioid medicines for pain relief
because of lack of clarity regarding the same within the NDPS Act. The ensuing Rules are
also such that it is difficult for hospitals to store and dispense narcotics meant for medical
use.
Institutions that require to store it have to obtain licences for stocking, import, export,
transport etc. each from different departments [Excise, Drugs Control, Health departments].
This makes it difficult for institutions to maintain valid licences for stocking narcotics with
required legal sanctions. Most institutions solve this problem by not stocking these
medicines at all to avoid legal hassles. This also includes most medical colleges in the
country; which usually have not stocked opioids since last 25 years.
Hence generations of doctors have passed out, who do not have any experience of using
these useful medicines and this has led to deep misconceptions and hesitation to use them.
The overall impact is that, the patients are not able to get access to these medicines for
their pain relief and have to go through much suffering.
4. Where there any action taken in all these years, to solve this problem?
In 1998, modified rules were formulated and directives were sent to all the states in the
country to follow them. Although few states did change the rules, it has not improved the
situation realistically.
A Public interest litigation was filed in 2007 by The Indian Association of Palliative Care
[IAPC] pleading for adequate access to pain relief for cancer patients in the country. This
case is presently with the Supreme Court and it has asked, Min of Health, Min of Finance,
the medical council of India etc. to respond adequately.
The opioid availability committee of IAPC, in collaboration with Lawyer’s collective1
suggested amendments to the Act and filed representations with the Department of
Revenue, Ministry of Finance and the Standing Committee on Finance. This has been
scrutinized, analyzed and incorporated in the NDPS (Amendment) Bill 2011, pending
currently for Parliament approval.
The amendment is aimed at ensuring availability of Essential narcotic drugs for medical
use for patients suffering from moderate to severe pain.
5. What are the important provisions of the amendment?
Currently, each state has its own regulations which vary from state to state. The
amendment will make them uniform for all states and union territories. With the proposed
amendments, there will be uniformity in the regulatory provisions in the country on few selected
medicines [Essential Narcotic Drugs]. The power to amend the rules on these drugs will be
vested with Central Government. Thus, in each state, instead of multiple agencies being
involved in the process of licensing, there will be only one – the drugs controller, which
would eliminate the cumbersome multi - departmental red tape. The overall expected impact
would be improved accessibility and availability of pain medications within health care
institutions.
6. With the amendment, will the entire process of narcotics control get transferred from
the States to the Central Government?
No. The amendments involve only very few essential narcotic drugs. Also, their licensing
and monitoring will be done by the State Drugs Controller.
7. What about its misuse and diversion?
There are existent systems in place in the country, to prevent misuse and diversion of
narcotics. Even with the current amendments, the procedures required to prevent misuse
and diversion would continue with the required emphasis.
Kerala is the earliest state to implement modified Rules and have a systematic policy to
make these drugs available for treating moderate to severe pain. A study done in Calicut Kerala in 2001, looked at 1723 patients who were being treated for their severe pain with
1
An NGO working in this area
oral morphine on an outpatient basis. Over the 2 years of the study, the investigators did
not identify any instances of misuse or diversion2.
The result of this Lancet study suggest that, after establishing medical necessity by a trained
professional, along with systematic record keeping and regular review, oral morphine can
be dispensed safely to patients with malignancy related pain, for use at home without fear
of misuse or diversion.
8. What are the dangers of using narcotics for medical use? Would patients stay doped
or die more quickly when using these drugs?
There are several misconceptions regarding their use. Patients do NOT stay sleepy / doped
when given Morphine for pain relief in an appropriate manner.
Many patients with advanced disease, who are bedridden mainly due to severe pain,
become more comfortable after starting oral morphine and survive the rest of their lives for
months or years with comfort and better quality of life. They are able to participate in daily
living because they are able to rest, sleep and eat better. They are also able to resume their
normal activities at work and at home and develop a renewed interest in life.
When morphine is prescribed when someone is very near to death, the cause of the event
is not particularly due to the opioid medicine, but due to the advanced nature of the
disease.
9. What is the support that is required?
We do want you to write to the Ministry of Finance in support of the bill for it to be brought
up for discussion during the winter session of Parliament due in Dec 2013. With the
limited time available, it is likely that only a few bills will be taken up. Patients in pain and
their families need help to ensure that the NDPS amendment is among the chosen few.
It is also hoped that the message reaches all those who can make a difference - the
Secretary General of Lok Sabha; the Finance minister; other ministers; the leaders of the
opposition and the public.
10. How many Indians could be benefitted from the amendment of this Act and improved
access to pain relief?
At least one million people with cancer, and possibly the same number of people with other
diseases.
2
Medical use, misuse, and diversion of opioids in India, M R Rajagopal, David E Joranson, Aaron M Gilson; THE
LANCET • Vol 358 • July 14, 2001