Curbing Black Marketing of Life Saving Drugs




Curbing Black Marketing of Life Saving Drugs

The Ministry of Health & Family Welfare does not have any information about black marketing of drugs. However, the State Drug Controllers are empowered under the Drugs & Cosmetics Act, 1940 and Rules thereunder for initiating action against such unauthorized activities.


Pricing of drugs is dealt with by the Department of Pharmaceuticals. As per information provided by that Department, 51 cancer medicines are included in the scheduled category of Drugs Price Control Order (DPCO) out of which National Pharmaceutical Pricing Authority has already notified the ceiling prices of 47 cancer medicines. No person is authorized to sell formulations at a price higher than the ceiling price of scheduled formulations fixed under DPCO, 2013. In respect of non-scheduled formulations, not covered under price control, manufacturers are not allowed to increase the price beyond the permissible limit of ten percent on a year to year basis under the provision of DPCO, 2013.

The Health Minister, Shri J P Nadda stated this in a written reply in the Rajya Sabha here today.

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Healthcare Facilities to Handle Cancer Cases

Cancer can be diagnosed and treated at various levels in the Government health care system. However, the number of teletherapy machines in the country is less than the norms of WHO and International Atomic energy Agency (IAEA). While health is a state subject, the Central Government supplements the efforts of the state governments for improving healthcare including prevention, diagnosis and treatment of cancer.

The Government of India had launched a comprehensive National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Disease and Stroke (NPCDCS) in 2010 with focus on three sites of cancer namely breast, cervical and oral Cancer. From 2013-14 onwards, interventions under NPCDCS for prevention, early detection, diagnosis and treatment of Cancer, which can be taken up upto district level, have been brought under the umbrella of National Health Mission.

In addition, the Government of India under “Strengthening of Tertiary Care of Cancer” scheme of NPCDCSwill assist 20 State Cancer Institutes (SCI) and 50 Tertiary Care Cancer Centres (TCCC) in different parts of the country. The maximum assistance inclusive of State Share for SCI is Rs.120 crores and for TCCC is Rs.45 crores.

The treatment of Cancer patients in various Government Hospitals is either free or subsidized both for the Central and State Government Hospitals. In addition to Cancer diagnosis and treatment by the State Governments Health Institutes, the Central Government Institutions such as All India Institute of Medical Sciences, Safdurjung Hospital, Dr Ram ManoharLohia Hospital, PGIMER Chandigarh, JIPMER Puducherry, Chittaranjan National Cancer Institute, Kolkata, etc. provide facilities for diagnosing and treatment of Cancer.

Oncology in its various aspects has focus in case of new AIIMS and many upgraded institutions under PradhanMantriSwasthyaSurakshaYojna (PMSSY). Moreover, to increase the number of seats in Super speciality course in Medical Oncology, Surgical Oncology and broad speciality course in Radiotherapy, the ratio of number of Post-Graduate (PG) teachers to the number of students to be admitted has been now increased to 1:3 for a Professor subject to a maximum of 6 PG seats per unit per academic year. Setting up of National Cancer Institute at Jhajjar (Haryana) and 2nd campus of Chittranjan National Cancer Institute, Kolkata has been approved.

The list of medicines specified in the National List of Essential Medicines (NLEM) which are included in the First Schedule of Drug Pricing Control Order (DPCO), 2013 also contain drugs used for the treatment of Cancer. 489 NLEM (drug formulations) medicines for which ceiling prices have been notified under DPCO, 2013, includes 47 anti-Cancer medicines. No person is authorized to sell any such formulation to any consumer at a price exceeding the ceiling price fixed by the National Pharmaceutical Pricing Authority (NPPA) under Ministry of Chemicals & Fertilizers.

Financial assistance to Below Poverty Line (BPL) patients is available under the RashtriyaArogyaNidhi (RAN). Besides this, the Health Minister’s Cancer Patient Fund (HMCPF) within the RashtriyaArogyaNidhi has been set up in 2009 wherein 27 erstwhile Regional Cancer Centres (RCCs) are provided with revolving funds to provide immediate financial assistance upto Rs.2.00 lakh to BPL Cancer patients.

The Health Minister, Shri J P Nadda stated this in a written reply in the RajyaSabha here today.


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Steps taken to Check Sale of Spurious Drugs

Isolated cases of export of drugs of sub-standard quality by some Indian pharmaceutical companies have appeared in the media and on the websites of the regulatory authorities of foreign countries, etc. from time to time. These include the websites of United State Food and Drugs Administration and Medicines and Healthcare Products Regulatory Agency, United Kingdom. Based on the samples taken by Central Drugs Standard Control Organization during 2011-12 to 2014-15 (up to September, 2014), 0.03% samples were found to be spurious or adulterated and 3.33% samples were found to be not of standard quality. Such medicines are not allowed to be sold either in the domestic or in other markets.

Samples are drawn by the officers of the Central Drugs Standard Control Organization (CDSCO) and State Drug Regulatory officials regularly and these are tested at the drug testing laboratories. In cases, where samples are not found to be conforming to quality, appropriate action is taken by the State Drug Regulators. These include suspension, cancellation, rejection or debarment of the license.

In order to check the problem of spurious/sub-standard drugs in the country, a number of steps have been taken by the Government. These include amendment to the Drugs and Cosmetics Act, 1940 which provides for stringent penalties for manufacture of spurious and adulterated drugs. Through that amendment, some offences have also been made cognizable and non-bailable. Further, 21 States/UTs have already set up Special Designated Courts for trial of such offences and the structures in the CDSCO have also been strengthened.

The Health Minister, Shri J P Nadda stated this in a written reply in the Rajya Sabha here today.

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Supply of Adulterated Milk by Private Dairies

As per the reports received from the State/UT governments, there are occasional instances of supply of sub-standard/adulterated milk.

The menace of food adulteration and particularly milk adulteration needs to be eliminated through a series of measures including effective implementation of the Food Safety and Standard Act by State Government, strengthening of the food safety structures in the country and to the extent necessary, by appropriately amending the laws after consultation with all concerned. While government will take all measures considered necessary for eliminating milk adulteration, even under the existing Food Safety and Standards Act, manufacturing, selling, distributing or importing unsafe food which includes milk, is punishable under Section 59. The penalties provided for in section 59 (iv) of this Act include imprisonment for not less than seven years which may extend to imprisonment for life and also fine of not less than Rs. 10 lakh.

The Health Minister, Shri J P Nadda stated this in a written reply in the Rajya Sabha here today.


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Free Supply of Essential and Life Saving Drugs


Public health being a state subject, under the National Health Mission (NHM), financial support is provided to the States/UTs for strengthening their healthcare delivery system including support for provision of free drugs to those who access public health facilities. The Government of India has provided for NHM-Free drug service initiative under NHM.

The support under NHM is provided based on requirements posed by States/UTs in their Programme Implementation Plans under NHM. The number of free drugs provided by the States varies from State to State.

The state-wise approvals provided for drugs under NHM for financial years 2012-13, 2013-14 and 2014-15 (up to December, 2014) is given below:-


*Support for Drugs Under National Health Mission
  (Rs. Crore)

States/UTs
2012-13
2013-14
2014-15#
Andaman & Nicobar Islands
1.59
0.38
0.29
Andhra Pradesh
35.06
59.26
109.65
Arunachal Pradesh
3.41
5.72
6.06
Assam
159.83
132.1
155.60
Bihar
91.12
155.7
150.64
Chandigarh
1.09
0
0.00
Chhattisgarh
8.23
51.67
94.44
Dadra & Nagar Haveli
0.67
0.37
0.98
Daman & Diu
0.22
0.12
0.17
Delhi
17.33
36.96
27.09
Goa
2.05
2.55
3.20
Gujarat
22.67
77.63
41.83
Haryana
22.65
40.78
57.57
Himachal Pradesh
4.89
11.22
28.82
Jammu & Kashmir
10.76
18.01
28.32
Jharkhand
35.48
39.51
41.58
Karnataka
58.47
67.14
79.33
Kerala
15.59
11.6
24.03
Lakshadweep
0.03
0.29
0.06
Madhya Pradesh
81.27
133.66
141.42
Maharashtra
83.43
275.81
336.81
Manipur
3.94
2.83
6.47
Meghalaya
8.37
5.57
10.97
Mizoram
4.82
4.31
5.19
Nagaland
9.64
2.44
6.02
Orissa
54.91
32.88
26.21
Puducherry
2.52
2.49
3.20
Punjab
45.14
74.77
67.29
Rajasthan
50.67
160.54
202.12
Sikkim
1.35
0.62
3.31
Tamil Nadu
71.19
71.35
90.31
Telangana
NA
NA
72.29
Tripura
11.05
5.82
13.12
Uttar Pradesh
196.45
242.21
292.24
Uttarakhand
12.02
10.97
9.18
West Bengal
84.93
136.75
129.60
Grand Total
1212.83
1874.04
2265.38

* Does not include kind grants. # upto December 2014. Source: State RoPs.

As regards proper monitoring of free availability of quality drugs in public health care facilities, substantial support to States/UTs for provision of free drugs under NHM is subject to the State fulfilling the following conditions:

·         It notifies or has a clearly notified policy of providing free essential drugs to all patients coming to public sector health facilities at least uptodistrict hospital level,
·         It has/ creates a robust procurement, logistics & supply chain system that is IT backed,
·         It has differential facility-wise essential drug list depending on the nature of the facility,
·         It has a sound drug regulatory and quality assurance system,
·         It lays down standard treatment guidelines and provides for prescription audits to ensure rational use of drugs.

The drugs procurement and logistics systems of the States are also reviewed by the National Health Systems Resource centre.

With regard to steps taken/being taken by the Government for proper monitoring of the funds, besides provision of annual audit by Comptroller and Auditor General, some of the key monitoring mechanisms put in place by the Central Government for adherence to finance procedures and proper financial utilization are as follows:

·         Submission of quarterly Financial Monitoring Reports by the States;
·         Annual Statutory Audits;
·         Concurrent Audits;
·         Implementation of Public Management System (PFMS) in NHM. The PFMS has been developed by the office of the CGA of the Ministry of Finance for monitoring and management of funds on just in time basis. Capacity building and sensitization of staff have been done. Efforts are being made to ensure registration up to the village level.
·         Regular reviews on NHM including on financial matters with State/UT government officials.
·         Visits by the team of Financial Management Group of the Department to States for periodical review;
·         Annual visits to States by Common Review Mission, which inter-alia, looks at financial system and mechanisms.

The Health Minister, Shri J P Nadda stated this in a written reply in the RajyaSabha here today.

Curbing Black Marketing of Life Saving Drugs Curbing Black Marketing of Life Saving Drugs Reviewed by Ajit Kumar on 11:07 PM Rating: 5

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