10-Dec-2018: ‘Many combination drugs not approved by regulator’
Of the 110 anti-TB (tuberculosis) Fixed Dose Combinations (FDCs) available in India, only 32 (less than 30%) have been approved by the Central Drugs Standard Control Organisation (CDSCO), the country’s drug regulator. In the case of malaria FDCs, only eight out of 20 (40%), have been approved.
These statistics, that give rise to safety and efficacy concerns, have been brought out in a study published online in the journal Tropical Medicine and International Health by researchers from the Manipal College of Pharmaceutical Sciences.
An FDC or combination product is a formulation with more than one active pharmaceutical ingredient (API) in a fixed ratio of doses formulated into a single dosage form.
Aimed at assessing the proportion and sales of unapproved FDCs of anti-tubercular, antimalarial and antiretroviral (anti-HIV/AIDS) medicines available in India, the study analysed the available FDCs for these diseases and screened them against the CDSCO database of approved FDCs.
An opaque regulatory framework and ambiguity over licensing powers have contributed to the problem. The rationality of unapproved FDCs should be reviewed and irrational formulations should be banned. As of April, the CDSCO had approved 1,288 FDCs. This is disproportionately high compared with the availability in a tightly regulated market like USFDA, which has only a few hundred approved FDCs.
Pointing out that even the World Health Organisation’s (WHO) list of essential medicines mentions only 24 FDCs; it is unfortunate that a majority of approved FDCs in the Indian market are irrational and lack scientific justification. The scientific rigour of the CDSCO in approving these FDCs has been questioned time and again in Parliamentary and academic reports.
The study quoted the Parliamentary Standing Committee on Health and Family Welfare, which in its 59th report in 2012, pointed out multiple deficiencies in the CDSCO’s approval process for FDCs. It highlighted institutional problems such as understaffing, lack of skills, and inadequate infrastructure. “However, the most significant observation concerned the issuance of manufacturing licenses by the State Licensing Authority without the prior clearance of the Drug Controller General of India DCG(I), the head of CDSCO. This is the main problem.
The problem of unapproved FDCs mainly affects those who get treated in the private sector. In the absence of a strong pharmacovigilance mechanism in India, there is no data on adverse events of these unapproved FDCs.
12-Sep-2018: Prohibition and restriction of manufacture, sale and distribution of Fixed Dose Combinations (FDCs)
The Ministry of Health and Family Welfare has prohibited the manufacture for sale, sale or distribution for human use of 328 Fixed Dose Combinations (FDCs) with immediate effect. It has also restricted the manufacture, sale or distribution of six FDCs subject to certain conditions.
Earlier, the Central Government had, through its notifications published on the 10th March, 2016 in the Gazette of India, prohibited the manufacture for sale, sale and distribution for human use of 344 FDCs under section 26 A of the Drugs and Cosmetics Act, 1940. Subsequently, the Government had prohibited five more FDCs in addition to the 344 under the same provisions.
However, the matter was contested by the affected manufacturers in various High Courts and the Supreme Court of India. In compliance with the directions given by the Supreme Court of India in its judgment dated the 15th December, 2017, the matter was examined by the Drugs Technical Advisory Board constituted under section 5 of the Drugs and Cosmetics Act, 1940 which furnished its report on these drugs to the Central Government. The Drugs Technical Advisory Board recommended, amongst other things, that there is no therapeutic justification for the ingredients contained in 328 FDCs and that these FDCs may involve risk to human beings. The Board recommended that it is necessary to prohibit the manufacture, sale or distribution of these FDCs under section 26 A of the Drugs and Cosmetics Act, 1940 in the larger public interest. With regard to six FDCs, the Board recommended that their manufacture, sale and distribution be restricted subject to certain conditions based on their therapeutic justification. Fifteen FDCs out of the 344 prohibited on the 10th March, 2016, which were claimed to be manufactured prior to 21stSeptember, 1988, have been kept out of the purview of current notifications.
Earlier, an Expert Committee appointed by the Central Government had also examined these FDCs and made recommendations in line with those of the Board as indicated above.
The Central Government considered the recommendations of the Expert Committee and Drugs Technical Advisory Board, and based on such consideration, it was concluded that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of these 328 FDCs in the country.
Accordingly, the Ministry of Health and Family Welfare has, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940,prohibited the manufacture for sale, sale or distribution for human use of 328 FDCs through its gazette notifications dated 7th September 2018; it has also restricted the manufacture, sale or distribution of six FDCs subject to certain conditions. These notifications will take immediate effect.
14-Dec-2018: Delhi HC sets aside govt order banning private firms from producing, selling oxytocin
The Delhi High Court has set aside a government order banning private firms from producing and selling oxytocin- a drug commonly used during childbirth to induce contractions and control bleeding.
A bench of Justices S Ravindra Bhat and A K Chawla said there was no scientific basis behind the Centre’s decision restricting private companies from making or supplying the drug, which helps new mothers lactate, to prevent its alleged misuse in the dairy sector for increasing milk production. The court said the centre’s order was “arbitrary and unreasonable.”
Oxytocin is naturally secreted by the pituitary glands of mammals during sex, childbirth, lactation or social bonding, and is sometimes called “love hormone”. It is chemically synthesised and sold by pharmaceutical companies across the world. It’s used during childbirth because it can contract the uterus and induce delivery, control bleeding, and promote the release of breast milk. An oxytocin injection is generally available for Rs 3-20 at any chemist.
As per the Centre’s April 27 notification, the state-run Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL) was solely allowed by the Centre to make the drug to meet the country’s needs. The high court on August 31 had suspended till September 30 the central government’s prohibition on sale and manufacture of oxytocin by private companies for domestic use. The stay was later extended till December 15.
6-Apr-2018: Government bans import of the hormone oxytocin
The Union government banned import of the hormone oxytocin to stop its misuse in the livestock industry. It's been reported to cause hormonal imbalances and shorten the lives of milch animals.
Often called the ‘love hormone’, oxytocin is released naturally in human bonding activities such as reproduction, childbirth and breastfeeding.
The government also asked customs officials to step up vigilance against those likely to try and smuggle oxytocin into India. The government has decided to rely on domestic production to satisfy requirements of the hormone.
The drug’s abuse in animals shortens their lives and makes them barren sooner. India halted retail sales of the prescription-only drug in 2014, but regulators have struggled to curb illegal sales, and the volume of imports is unclear.
The ban follows an order by the drugs regulator last year for officials to clamp down on factories that produce the hormone in bulk despite not meeting manufacturing standards. A panel of top drug experts had recommended an import ban in February, the minutes of their meeting, posted on the drug regulator’s website.
It also recommended that sale be limited to registered government hospitals and clinics, a bar code system used on all forms of the drug to ensure tracking and prevent abuse.
21-Nov-2018: ICMR releases guidelines for judicious use of antibiotics
To ensure judicious use of antibiotics in healthcare facilities, the Indian Council of Medical Research (ICMR) released on November 20, Antimicrobial Stewardship Guidelines to advise hospitals in setting up Antimicrobial Stewardship Programmes (AMSP) for the purpose.
Antimicrobial resistance (AMR) is a major public health challenge, which is recognized as high priority area by the Government of India. The increasing consumption of antibiotics is one of the key drivers of antimicrobial resistance seen in bugs of public health importance. Irrational prescription of broad-spectrum antibiotics, poor regulations around sale of antibiotics, self-medication, lack of education and awareness regarding responsible use of antibiotics have been identified as some of the key factors driving antimicrobial resistance in our country. The ‘National Health Policy’ (2017), addresses antimicrobial resistance as one of the key issues and prioritises development of guidelines regarding antibiotic use, limiting the over-the-counter use of antibiotics, restricting the use of antibiotics as growth promoters in livestock, and pharmaco-vigilance including prescription audit inclusive of antibiotic usage in the hospital and community.
Hospital based programs dedicated to improving antibiotic use, commonly referred to as Antimicrobial Stewardship Program (AMSP) have been found helpful in improving the quality of patient care and safety through increased infection cure rates, reducing treatment failures, and increasing the frequency of correct prescription for therapy and prophylaxis. Implementation of an effective AMSP requires a multidisciplinary approach involving a variety of experts. Unfortunately, most of hospitals in India lack structure and process of AMSP. Recognizing the importance to create AMSP structures in health care institutions in the country, ICMR has initiated AMSP activities by developing AMSP curriculum, conducting workshops and developing AMSP research projects. ICMR has developed AMSP guidelines, which will be of immense help to the hospitals to create their own AMS program. This guideline will inform, encourage and support health care institutions to initiate the implementation of antimicrobial stewardship initiatives, as well as combating antimicrobial resistance.