Evidence map›Paper›PMID 41372687›Full record

ArticlePharmaceutical research2026

From Clinical Trials to Commercialization: Perspectives in Human Vaccine.

Nidhi Mehrotra, Padmavati Manchikanti

Abstract read
PubMed Publisher
In one paragraph

Article in Pharmaceutical research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors.

Nidhi MehrotraRajiv Gandhi School of Intellectual Property Law, Indian Institute of Technology Kharagpur, Kharagpur, West Bengal, 721302, India.
Padmavati ManchikantiRajiv Gandhi School of Intellectual Property Law, Indian Institute of Technology Kharagpur, Kharagpur, West Bengal, 721302, India. mpadma@rgsoipl.iitkgp.ac.in.ORCID http://orcid.org/0000-0002-7107-3675

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Although India ranks among the largest producers and exporters of human vaccines, the delay in launch of newer therapeutics is larger than the average in G20 nations. This study aims to assess the stakeholders' perspective on the coherence, clarity, and operational impact of the New Drugs and Clinical Trial (NDCT) Rules 2019. The analysis revealed a nuanced appraisal of the NDCT Rules wherein three major clusters of challenges faced by pharmaceutical companies are regulatory, operational, and systemic. The regulatory barriers encompass prolonged approval timelines, ambiguous legal mechanisms, fragmented oversight across agencies. Operational factors include uneven distribution of trial sites, inadequate site capacity, ethics committee delays. Systemic challenges centred on non-uniform trial protocols, inconsistent documentation practices and absence of harmonized operational guidelines.

Indexed as

Clinical Trials as TopicDrug ApprovalDrug IndustryVaccinesHumansIndiaVaccinesclinical trialshuman vaccinesIndianew drugs and clinical trials rules 2019pharmaceutical industry

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.